Lower risk Medical device recall · FDA · Published August 30, 2021

Exactech - Medical Devices

Exactech is a leading medical device manufacturer specializing in orthopedic, cardiovascular, and surgical implants. Their products include joint replacements, spinal implants, and cardiovascular devices.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0021-2022Medical device Exactech ›

Lower-risk recall

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

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Contact the company

Recalling firmExactech, Inc.2320 Nw 66th Ct · Gainesville, FL 32653-1630

✎ GovInfoNow plain-language explainer

Exactech is a leading medical device company that specializes in orthopedic, cardiovascular, and surgical implants. They are known for their high-quality products such as joint replacements, spinal implants, and cardiovascular devices. Read more at govinfonow.com/recall/61862-exactech-medical-devices.

Source Summary by GovInfoNow · govinfonow.com/recall/61862-exactech-medical-devices · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0021-2022

Cite this page

“Exactech - Medical Devices.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/61862-exactech-medical-devices. Based on FDA recall #Z-0021-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0021-2022%22&limit=1).

The FDA has issued a Class II recall for Exactech, Inc. reverse shoulder humeral liners due to articular surface misalignment risks.

How to tell if you have it

Exactech, Inc.
reverse shoulder humeral liners
Class II
FDA

The hazard

The reverse shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling, which may lead to improper fit and function.

Context

Exactech, Inc. has 34 other recalls on record since June 23, 2017. Recent recalls include the Equinoxe Ergo Ergo Modular Impactor Handle (missing cross-pin hazard), the Equinoxe Ergo Adjustable Angle rTSA Reamer 46mm (design updates not completed), and the current reverse shoulder humeral liners recall.

How to tell if you have this one

Check for proper medical device certifications (e.g., FDA approval), manufacturer recommendations, and regular follow-up with healthcare providers.

Brand
Exactech
Category
Medical device

FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide distribution and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, ECUADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GHANA, GREAT BRITAIN, GREECE, GUATEMALA, INDIA, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, ROMANIA, SINGAPORE, SPAIN, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TUNISIA, TURKEY, VENEZUELA .

Recall number	Product, codes & lots	Quantity
Z-0019-2022	OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.; a. Item Number (Device Identifier; Serial number(s)): 200-11-11 (10885862039934; 1010599); 200-12-09 (10885862039965; 0850770, 0850771, 0850773, 0850776, 0850778, 1052587, 1052589, 1070149, 1070150, 1070151, 1070152, 1267585, 1267586, 1267588, 1318739, 1318740, 1318742, 1375833, 1375836, 1375837, 1375839, 1375844); 200-12-11 (10885862039972; 0825651, 0825653, 0825654, 0825657, 0825659, 1052802, 1052803, 1052804, 1309224); 200-12-13 (10885862039989; 0763041, 0763043, 0820424, 0820431, 1053775); 200-13-09 (10885862039996; 0765380, 0765381, 0765382, 0765383, 0789723, 0789724, 0789726, 0789727, 0789728, 0789729, 0789730, 0789731, 0789732, 0897683, 0998654, 0998655, 0998656, 0998657, 0998658, 0998659, 0998660, 0998661, 0998662, 0998663, 0998664, 0998665, 0998666, 1073908, 1073909, 1073910, 1073911, 1084202, 1084203, 1084204, 1084205, 1261436, 1261437, 1261438, 1261439, 1261440, 1316122, 1316123, 1316124, 1316125, 1316126, 1319147, 1319148, 1319149, 1319150, 1319151, 1407772, 1407774, 1407775, 1407776, 1407777, 1407778, 1407779, 1407780, 1407781, 1516714, 1516715, 1516716, 1516717, 1516718, 1976718, 1976719, 1976720, 1976721, 1976722, 2061574, 2097473, 2097474, 2097475, 2097476, 2097477, 2097478, 2097479, 2145890, 2145891, 2145892, 2145894, 2145895, 2145896, 2559776); 200-13-11 (10885862040008; 0769998, 0770002, 0770003, 0770004, 0818558, 0818559, 0818560, 0818562, 0818563, 0818564, 0818565, 1027748, 1027750, 1027752, 1027754, 1084902, 1291129, 1291130, 1291131, 1319746, 1319747, 1319748, 1319752, 1319753, 1319754, 1319756); 200-13-13 (10885862040015; 0767606, 0767607, 0767608, 0767609, 0953412, 1063120, 1307627); 200-14-09 (10885862040039; 0607230, 0607231, 0607232, 0607233, 0607234, 0607235, 0607236, 0607237, 0607238, 1033676, 1033677, 1033678, 1033679, 1040785, 1040786, 1040787, 1040788, 1065019, 1065020, 1065021, 1065022, 1065023, 1065024, 1065025, 1153592, 1153593, 1153594, 1153595, 1153596, 1153597, 1153598, 1153599, 1153600, 1215318, 1215319, 1215320, 1215322, 1281462, 1281463, 1281464, 1281465, 1321078, 1321079, 1321080, 1321081, 1321082, 1389683, 1389684, 1389685, 1400987, 1400988, 1400989, 1400990, 2012144, 2012145, 2048510, 2048511, 2207641, 2207642, 2207643, 2345327, 2345328, 2414649, 2414652, 2454327, 2454328, 2454329, 2565530, 2565533, 2565534); 200-14-11 (10885862040046; 0942385, 0942386, 0942393, 1050502, 1310607); 200-14-13 (10885862040053; 0942535, 1048228, 1048232, 1153792); 200-15-09 (10885862040077; 0822759, 0822761, 0822762, 0822764, 0822765, 0822766, 0822767, 1048609, 1048611, 1048612, 1048614, 1048615, 1048616, 1048617, 1136150, 1136151, 1136152, 1136154, 1214791, 1214792, 1214793, 1214794, 1214795, 1214796, 1283152, 1283153, 1283154, 1283155, 1439852, 1439853, 1439855, 1439856, 2146108, 2146113); 200-15-11 (10885862040084; 1065636, 1065638); 200-15-13 (10885862040091; 0954497, 0954501); 200-16-11 (10885862040121; 1040633, 1040634, 1040635, 1040636, 1073405, 1073407, 1084258); 200-16-13 (10885862040138; 0956887); b. Item Number (Device Identifier; Serial number(s)): 204-11-09 (10885862047823; 0961663, 0961665, 0961666, 0961667, 0961668, 0961669, 0961671, 0961672, 1045876, 1045877, 1045879, 1070620, 1070622, 1070623, 1106799, 1106800, 1106801, 1106802, 1106803, 1106805, 1106807, 1193435, 1193437, 1193438, 1193439, 1232147, 1232151, 1255910, 1255911, 1255912, 1255913, 1255914, 1270806, 1270807, 1270808, 1270809, 1308220, 1308221, 1308222, 1308223, 1308224, 1308225, 1377016, 1377017, 1377018, 1377019, 1377020, 1377021, 1377022, 1377023, 1377024, 1377025, 1545261, 1545262, 1545263, 1545264, 1545265, 1565700, 1565701, 1565702, 1565703, 1565704, 1582779, 1582780, 1582781, 1582782, 1582783, 1582784, 1582785, 1582786, 1582787, 1582788, 1582789, 1582790, 1582791, 1582792, 1582793, 1582794, 1582795, 1582796, 1582797, 1582798, 1659777, 1659778, 1659779, 1659780, 1659781, 1659782, 1659783, 1659784, 1659785, 1659786, 1659787, 1659788, 1659789, 1659790, 1659791, 1659792, 1659793, 1659794, 1659795, 1659796, 1659797, 1659798, 1659799, 1659800, 1659801, 1704209, 1704210, 1704211, 1704212, 1786558, 1786559, 1786560, 1786561, 1786562, 1786563, 1786564, 1786565, 1797016, 1797017, 1797018, 1797019, 1797020, 1797021, 1797022, 1797023, 1797024, 1797025, 1797026, 1797027, 1797028, 1817561, 1817562, 1817563, 1817564, 1817565, 1817566, 1817567, 1817568, 1817569, 1817570, 1817571, 1817572, 1817573, 1842319, 1842320, 1842321, 1842324, 1842325, 1901249, 1901250, 1901251, 1901252, 1901253, 1901255, 1901256, 1901259, 1901260, 1901261, 1901262, 1901263, 1901264, 1901265, 1901266, 1901267, 1901268, 1901269, 1901270, 1901271, 1901272, 1901273, 1901274, 1901275, 1901276, 2266634, 2266635, 2266636, 2266638, 2276586, 2276587, 2276588, 2276589, 2397396, 2397397, 2397398, 2397399, 2397400, 2397401, 2397402, 2397403, 2397404, 2397405, 2425639, 2425640, 2425641, 2425642, 2425643, 2425644, 2425645, 2425646, 2425647, 2425648, 2425650, 2425651, 2425652, 2425653, 2425654, 2425655, 2425656, 2430257, 2430258, 2430259, 2430260, 2430261, 2430262, 2430263, 2430264, 2430265, 2615191, 2615192, 2615193, 2615194, 2615195, 2615196, 2615197, 2615198, 2615199, 2615200, 2653102, 2653103, 2653104, 2653105, 2653106, 2653107, 2653108, 2653109, 2653110, 2653111, 2653112, 2653113, 2653114, 2653115, 2653116, 2653117, 2653118, 2653119, 2653120, 2653121, 2653123, 2653124, 2653125, 2653126, 2653127, 2653128, 2653129, 2653130, 2653131, 3545584, 3545585, 3545586, 3545587, 3545588, 3545589, 3545590, 3545591, 3545592, 3545593, 3636693, 3636694, 3636695, 3636696, 3636697, 3636698, 3636699, 3636700, 3636701, 3636702, 3654361, 3654362, 3654363, 3654364, 3654365, 3654366, 3654367, 3654368, 3654369, 3654370, 3660720, 3660721, 3660722, 3660723, 3660724, 3781241, 3781242, 3781243, 3781244, 3781245, 3792869, 3792870, 3792871, 3792872, 3792873, 3809326, 3809327, 3809328, 3809329, 3809330, 4080806, 4080807, 4080808, 4080809, 4080810, 4080811, 4080812, 4080813, 4080814, 4080815, 4149218, 4149219, 4149220, 4149221, 4149222, 4175249, 4175250, 4175251, 4175252, 4175253, 4175254, 4175255, 4175256, 4205182, 4205183, 4205184, 4205185, 4205186, 4331818, 4331819, 4331820, 4331821, 4331822, 4331823, 4331824, 4331825, 4331826, 4367437, 4367438, 4367439, 4367440, 4367441, 4367442, 4367443, 4367444, 4399568, 4399569, 4399570, 4399571, 4399572, 4399573, 4399574, 4399575, 4399576, 4399577, 4933848, 4933849, 4933851, 4933852, 4933853, 4933854, 4933855, 4933856, 4933857, 4933858, 4933859, 4933860, 4933861, 4933862, 4933863, 4933864, 4933865, 4933866, 4933867, 4933868, 4933869, 4933870, 4933871, 4933872, 4933873, 4933874, 4933875, 4933876, 4933877, 4933878, 4933879, 4933880, 4933881, 4933882, 4933883, 4933884, 4933885, 4933887, 4945297, 4945298, 4945299, 4945300, 4945301, 4945302, 4945303, 4945304, 4945305, 4945306, 4945307, 4945308, 4945309, 4945310, 4945311, 4945312, 4945313, 4945314, 4945315, 4945316, 4945317, 4945318, 4945319, 4945320, 4945321, 4945322, 4945323, 4945324, 4945325, 4945326, 4945327, 4945328, 4945329, 4945330, 4945331, 4945332, 4945333, 4945334, 5086208, 5086209, 5086210, 5086211, 5086212, 5086213, 5086214, 5086215, 5086216, 5086217, 5086218, 5086219, 5086220, 5172053, 5172054, 5172055, 5172056, 5172057, 5172058, 5172059, 5180020, 5180021, 5180022, 5180023, 5180024, 5180025, 5180026, 5188774, 5188775, 5188776, 5209513); 204-11-11 (10885862047830; 0971418, 0971419, 0971420, 0971421, 0971422, 0971423, 1015616, 1015617, 1015618, 1015619, 1047575, 1047577, 1047578, 1066792, 1066793, 1066794, 1087082, 1087083, 1087084, 1087085, 1087086, 1168686, 1168687, 1187090, 1187092, 1187093, 1187094, 1187096, 1187098, 1187099, 1255900, 1255901, 1255902, 1255903, 1255904, 1255905, 1255906, 1255907, 1255908, 1255909, 1270537, 1270540, 1294283, 1294284, 1294285, 1294287, 1294288, 1294289, 1294290, 1307222, 1307223, 1307224, 1307225, 1392229, 1392230, 1392231, 1392232, 1392233, 1576699, 1576700, 1576701, 1576702, 1576703, 1576704, 1576705, 1585601, 1585602, 1585603, 1585604, 1585605, 1585606, 1585607, 1585608, 1585609, 1585610, 1585611, 1585612, 1585613, 1585614, 1585615, 1585616, 1585617, 1585618, 1585619, 1585620, 1585621, 1585622, 1585623, 1585624, 1585625, 1585626, 1585627, 1585628, 1585629, 1585630, 1585631, 1585632, 1745600, 1745601, 1745602, 1745603, 1745604, 1774126, 1774127, 1774128, 1774129, 1774130, 1774131, 1774132, 1774133, 1774134, 1774135, 1774136, 1774137, 1786761, 1786762, 1786763, 1786764, 1786765, 1786766, 1786767, 1786768, 1810253, 1810254, 1810255, 1810256, 1810257, 1810258, 1810259, 1810260, 1810261, 1821731, 1821732, 1821733, 1821734, 1821735, 1821736, 1821737, 1821738, 1821739, 1821740, 1821741, 1865512, 1865513, 1865515, 1897369, 1897370, 1897371, 1897373, 1897374, 1897375, 1897376, 1897377, 2265900, 2265901, 2265902, 2265903, 2265904, 2306144, 2306145, 2306146, 2306147, 2306148, 2306149, 2306150, 2306151, 2306153, 2306154, 2306155, 2306156, 2306157, 2306158, 2306159, 2306160, 2306161, 2306163, 2306164, 2306165, 2306166, 2306167, 2306168, 2306169, 2306170, 2306171, 2306172, 2430406, 2430407, 2430408, 2430409, 2430410, 2430411, 2430412, 2430413, 2430414, 2430415, 2582070, 2582071, 2582072, 2582073, 2582074, 2582075, 2582076, 2628063, 2628064, 2628065, 2628066, 2628067, 2628068, 2628069, 2628070, 2628071, 2628072, 2628073, 2628074, 2628075, 3545581, 3545582, 3545583, 3616391, 3616392, 3616393, 3616394, 3616395, 3636926, 3636927, 3644006, 3654371, 3654372, 3654373, 3654374, 3654375, 3654376, 3729486, 3756690, 3775777, 3775778, 3776705, 3776706, 3776707, 3776708, 3776709, 3811782, 3811783, 3811784, 3811785, 3811786, 3811787, 3811788, 3811789, 3811790, 3811791, 4053394, 4053395, 4053396, 4053397, 4053398, 4053399, 4053400, 4053401, 4053402, 4053403, 4053404, 4053405, 4053406, 4053407, 4053408, 4205187, 4205188, 4205189, 4205190, 4205191, 4226766, 4226767, 4226768, 4226769, 4226770, 4226772, 4226773, 4226774, 4226775, 4349216, 4349217, 4349218, 4349219, 4349220, 4349221, 4349222, 4349223, 4349224, 4384105, 4384106, 4384107, 4384108, 4384109, 4384110, 4384111, 4384112, 4384113, 4384114, 4816187, 4816188, 4816189, 4846027, 4846028, 4846029, 4846030, 4846031, 4846032, 4846033, 4846034, 4846035, 4846036, 4846037, 4846038, 4846039, 4846040, 4846041, 4846042, 4846043, 4846044, 4846045, 4846046, 4846047, 4846048, 4846049, 4846050, 4846051, 4846052, 4934866, 4934867, 4934868, 4934869… Full codes in the FDA record	242,397 devices
Z-0020-2022	OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.; Item Number (Device Identifier; Serial number(s)): 252-12-01 (10885862065759; 0757895, 0757903, 0757904, 0757912, 0779752, 0779753, 0779755, 0779756, 0779757, 0779761, 0779762, 0779763, 0779764, 0779765, 0779766, 0779768, 0779769, 0779771, 1411813, 1411814, 1411816, 1454118, 1454120, 1454121, 1454122, 1637857, 1637859, 1637862, 1637863, 1705486, 1705487, 1705488, 1705489, 1705491, 1705492, 1705499, 1705500, 1777268, 1777272, 1838362, 1838363, 1838366, 1845014, 1845017, 1845018, 1876225, 1876228, 1876229, 1966561, 1966562, 1966563, 1966565, 2058877, 2058880, 2058883, 2236096, 2236097, 2236100, 2388362, 2388363, 2388364, 2388365, 2782155, 2787073, 2787075, 2787076, 3664728, 3664729, 4149824, 4149840); 252-12-02 (10885862065766; 1064337, 1064339, 1064340, 1064341, 1064342, 1064343, 1064344, 1064345, 1064347, 1064348, 1064349, 1064350, 1064351, 1064352, 1064353, 1064354, 1064355, 1064356, 1064357, 1064358, 1257124, 1257125, 1257126, 1257127, 1257128, 1257130, 1257131, 1257132, 1257135, 1257136, 1257138, 1257141, 1257145, 1257146, 1257147, 1257148, 1257149, 1257150, 1257151, 1257152, 1257153, 1257154, 1257156, 1257157, 1257158, 1257159, 1257160, 1257163, 1257164, 1257165, 1257166, 1257167, 1257168, 1257169, 1257170, 1257171, 1257173, 1257175, 1257176, 1257177, 1257178, 1257179, 1257181, 1856545, 1856546, 1856547, 1856549, 1856550, 1856551, 1856552, 1856554, 1896395, 1896396, 1896397, 1896398, 1896399, 1896400, 1896401, 1896404, 2116639, 2116640, 2116641, 2116642, 2116644, 2288472, 2328963, 2328964, 2328965, 2328966, 2328968, 2509909, 2509911, 2566818, 2649854, 2692694, 2728962, 2728968, 2728971, 2728976, 2728977, 2728979, 2728980, 2728981, 2728988, 2728991, 3808095, 3808101, 3808110, 3808112, 3808116); 252-12-03 (10885862065773; 0764379, 0764380, 0764381, 0764382, 0764384, 0764385, 0764386, 0764387, 0764389, 0764390, 0764391, 0764392, 0764393, 0764394, 0764395, 0764396, 0764398, 0764400, 0764401, 0764402, 0764407, 0766178, 0766179, 0766180, 0766181, 0766182, 0766183, 0766185, 0766188, 0766189, 0766191, 0766193, 0766194, 0766195, 0766196, 0766198, 0766199, 0766200, 1152751, 1152756, 1152758, 1152759, 1152760, 1152763, 1152764, 1152765, 1152767, 1152768, 1152769, 1248425, 1248426, 1248427, 1248429, 1248430, 1248431, 1248432, 1248433, 1248434, 1248435, 1248437, 1248438, 1248439, 1248440, 1248441, 1248442, 1248443, 1248444, 1248445, 1248446, 1248447, 1248448, 1248449, 1248450, 1294270, 1294271, 1294272, 1294273, 1294274, 1294275, 1294276, 1294277, 1294278, 1294279, 1434902, 1434903, 1434904, 1434905, 1434906, 1434907, 1434908, 1434909, 1434910, 1510648, 1510649, 1510650, 1510651, 1526390, 1526391, 1526392, 1526393, 1545560, 1545561, 1548840, 1548841, 1548842, 1617606, 1617607, 1617608, 1617609, 1617610, 1617611, 1618554, 1618555, 1618556, 1618557, 1618558, 1706098, 1706099, 1706100, 1706101, 1706102, 1706104, 1706105, 1706106, 1706107, 1706108, 1706109, 1706110, 1778471, 1778472, 1778473, 1778474, 1778475, 1778476, 1778477, 1778478, 1778479, 1778480, 1778481, 1778482, 1778483, 1778484, 1778485, 1778486, 1778487, 1825147, 1825148, 1825149, 1825150, 1825151, 1825153, 1846127, 1846128, 1846129, 1846130, 1846131, 1846132, 1846133, 1846134, 1846135, 1846136, 1846137, 1933648, 1933649, 1933650, 1933651, 1936093, 1936094, 1936095, 2002988, 2002989, 2002990, 2002991, 2002992, 2002993, 2002994, 2049677, 2049678, 2049679, 2049680, 2049681, 2060180, 2087493, 2087494, 2087495, 2087496, 2087497, 2087498, 2087499, 2087500, 2087502, 2087503, 2087504, 2087506, 2087507, 2205053, 2205054, 2205055, 2205057, 2233544, 2233545, 2233548, 2233549, 2233550, 2233551, 2233553, 2233554, 2233555, 2233556, 2233557, 2233558, 2512172, 2512173, 2567163, 2567164, 2567165, 2567166, 2567168, 2567169, 2567171, 2567172, 2787069, 2787070, 2787071, 2787072, 2829262, 2829263, 2829264, 2906611, 2906612, 2906613, 2991360, 2991362, 2991363, 2991365, 3564018, 3564020, 3564021, 3564022, 3564023, 3564024, 3564025, 3564026, 3691658, 3808084, 3808085, 3808086, 3808089, 3808093, 4279265, 4279268, 4279270, 4279271, 4488796, 4677196, 5839504, 5839509, 5839510, 5839512, 5839513, 5839514, 5839517, 5839518, 5839519, 5839528, 5839531, 5839532, 5839533, 5839534, 5839535, 5839536, 5839537, 5839538, 5839539, 5839540, 5839541, 5839542, 5839543, 5839545, 5839549, 5839550, 5839557, 5839560); 252-12-04 (10885862065780; 1085902, 1085903, 1085904, 1085905, 1085906, 1085907, 1085908, 1085909, 1085911, 1085914, 1085915, 1085916, 1085917, 1085918, 1085919, 1085920, 1085921, 1085922, 1085923, 1085924, 1174118, 1174119, 1174120, 1174121, 1174122, 1174123, 1174124, 1174125, 1174126, 1174127, 1174129, 1174130, 1174131, 1174132, 1174133, 1174134, 1174136, 1174137, 1174139, 1174140, 1174141, 1174142, 1174143, 1174144, 1174145, 1174146, 1174147, 1174148, 1174149, 1174150, 1174151, 1174152, 1174153, 1174154, 1174155, 1174156, 1174157, 1174158, 1174159, 1174160, 1174161, 1174162, 1174163, 1174164, 1174165, 1174166, 1174168, 1174169, 1174170, 1174171, 1544907, 1544908, 1544909, 1544910, 1600619, 1600620, 1600621, 1600622, 1600623, 1600624, 1600625, 1600626, 1600627, 1600628, 1600629, 1603583, 1603584, 1603585, 1603586, 1603587, 1603588, 1603589, 1603590, 1603591, 1603592, 1603593, 1603594, 1603595, 1603596, 1603597, 1838244, 1838245, 1838247, 1838248, 1838250, 1838251, 1838252, 1838253, 1838254, 1838255, 1838256, 1838257, 1838258, 1838259, 1838260, 1838261, 1876049, 1876050, 1876051, 1876052, 1876053, 1876054, 1876055, 1876056, 1876057, 1876058, 1877196, 1877197, 1877198, 1877199, 1877200, 1877201, 1877203, 1877204, 1877205, 1877206, 1877207, 1877209, 1877210, 2080039, 2080040, 2080041, 2080042, 2080043, 2080044, 2080048, 2080049, 2080050, 2080051, 2204986, 2204987, 2235110, 2235111, 2235112, 2235113, 2235114, 2235115, 2235116, 2235117, 2235118, 2235119, 2235121, 2235122, 2235124, 2567173, 2567174, 2742317, 2742318, 2742319, 2742320, 2742321, 2742322, 2742323, 2892691, 2892692, 2892693, 2892694, 2892695, 2980254, 2980255, 2980256, 2980257, 2980258, 2980259, 2980260, 2980262, 2980263, 2980264, 2980265, 2980266, 2980267, 2995492, 2995494, 2995496, 2995498, 2995500, 2995502, 3624142, 3624143, 3624145, 3624148, 3624150, 3728981, 3755632, 3791754, 3791756, 3791757, 3791758, 3791759, 3971565, 3971566, 3971567, 3971568, 3971569, 3971570, 4019996, 4019997, 4019998, 4020000, 4058269, 4058270, 4058271, 4298553, 4298556, 4298557, 4298558, 4298560, 4298561, 4298563, 4298564, 4298565, 4298566, 4719674, 4719677); 252-12-05 (10885862065797; 0764354, 0764356, 0764358, 0764359, 0764360, 0764361, 0764363, 0764364, 0764366, 0764367, 0764368, 0764369, 0764371, 0764372, 0776484, 0776485, 0776486, 0776487, 0776489, 0776491, 0776492, 0776497, 0776499, 0776500, 0776501, 0776502, 0776505, 0776506, 0776507, 0776508, 1344152, 1344153, 1344155, 1344156, 1344157, 1344158, 1344159, 1344160, 1344161, 1413174, 1413175, 1413176, 1413177, 1429614, 1429615, 1429616, 1429617, 1429618, 1429619, 1429620, 1429621, 1429622, 1429623, 1443143, 1443144, 1443145, 1443146, 1443147, 1513762, 1513763, 1513764, 1513765, 1513766, 1513767, 1513768, 1513769, 1513770, 1513771, 1722792, 1722794, 1722796, 1722797, 1722799, 1722800, 1722802, 1722803, 1722804, 1722805, 1722806, 1786482, 1786483, 1786485, 1786486, 1786487, 1786488, 1786492, 1786494, 1786495, 1786496, 1845431, 1845433, 1845435, 1932090, 1932091, 1932092, 1932093, 1932094, 2039276, 2049683, 2138747, 2138748, 2138749, 2138750, 2138751, 2138752, 2152317, 2152318, 2152319, 2152320, 2152322, 2236090, 2236091, 2236094, 2236095, 2287646, 2287648, 2287649, 2287650, 2351082, 2351083, 2351084, 2464982, 2464983, 2567177, 2782410, 2782411, 2796910, 2796911, 2796912, 2796913, 2796915, 2796916, 2877828, 2877831, 2965401, 2965402, 2965403, 2991358, 3122647, 3122648, 3122649, 3122650, 3546828, 3546829, 3546831, 3669732, 3669733, 3669735, 3669736, 3669737, 3699151, 3699152, 3808117, 3808118, 3808119, 3808120, 3808122, 4005870, 4005871, 4005872, 4005873, 4005874, 4046964, 4046965, 4133012, 4133014, 4133015, 4133017, 4133020, 4133021, 4133024, 4133028, 4133030, 4133032, 4133033, 4133034, 4133035); 252-12-06 (10885862065803; 0764251, 0764255, 0764256, 0764258, 0764260, 0764261, 0764264, 0764265, 0764267, 0764268, 1527895, 1704849, 1704850, 1704851, 1704853, 1704855, 1705430, 1705431, 1774436, 1774437, 1774438, 1774439, 1790515, 1790521, 1790522, 1790523, 1790524, 1790525, 1790526, 2502380, 2535994, 2535995, 2535996, 2535997, 2535998, 2535999, 2536000, 2566819, 2566820, 2566821, 2742308, 2742309, 2742310, 2742311, 2742312, 2742314, 2742315, 2742316, 2906750, 2972415, 2972418, 2972419, 3669846, 3728978, 3792365, 3808124, 3808125, 3808126, 3808127, 3808131, 3965029, 3965030, 3965031, 3965032, 3965033, 3965034, 3965035, 3965036, 4093360, 4093361, 4093362, 4093363, 4093364, 4093365, 4093366, 4093367, 4093368, 4093369, 4093370, 4093372, 4093373, 4093374, 4149809, 4149813, 4149820, 4149821, 4149822); 252-13-01 (10885862065810; 0757154, 0757157, 0757162, 0757164, 0757167, 0757168, 0757169, 0757172, 0757173, 0779683, 0779687, 0779688, 0779690, 0779695, 0779698, 0779700, 0779702, 0779704, 0779705, 0779706, 1444543, 1444544, 1444546, 1444547, 1454184, 1637927, 1637931, 1637932, 1637934, 1637941, 1772248, 1772249, 1772250, 1772251, 1772252, 1772253, 1772254, 1772259, 1772260, 1772262, 1772265, 1772267, 1772268, 1772269, 1772270, 1772271, 1772273, 1997498, 2025207, 2025209, 2025210, 2025211, 2059074, 2059076, 2059077, 2059082, 2059083, 2350825, 2350826, 2350828, 2350829, 2446052, 2446054, 2446057, 2446058, 3669847, 3669848, 3728983, 3728984, 3808079, 3808080, 4361052); 252-13-02 (10885862065827; 1019275, 1019276, 1019277, 1019278, 1019279, 1019280, 1019282, 1019283, 1019284, 1019285, 1019286, 1019287, 1019288, 1019289, 1019290, 1019291, 1019292, 1019294, 1102287, 1102288, 1102289, 1102290, 1102291, 1102294, 1102296, 1102297, 1102299, 1102303, 1102304, 1102305, 1102306, 1102308, 1102309, 1107608, 1107610, 1107611, 1107613, 1107615, 1107616, 1107617, 1107618, 1107620, 1107621, 1107626, 1107627, 1107629, 1107630, 1107631, 1454672, 1454673, 1454674, 1601453, 1601454, 1601455, 1601456, 1601458, 1601459, 1601461, 1603598, 1603599, 1603600, 1603601, 1603602, 1603603, 1603605, 1603606, 1603607, 1704431, 1704432, 1704433, 1704434, 1704435, 1704436, 1704438, 1704439, 1704440, 1784663, 1838357, 1838358, 1838359, 1838361, 1838780, 1838781, 1838782, 1856535, 1856536, 1856537, 1856539, 1856540, 1856541, 1856542, 1856543, 1856544, 1927753, 1927754, 1927756, 1927758, 1927759, 2183886, 2183888, 2183889, 2377737, 2377738, 2377742, 2464981, 2512167, 2512170, 2512171, 2887563, 2887564, 2887570, 2887571, 2887575, 2887580, 2887585, 3792363, 3808148, 3808153, 3808154, 3808155, 3808159); 252-13-03 (10885862065834, 0816528, 0816529, 0816530, 0816531, 0816532, 0816533, 0816534, 0816535, 0816537, 0816538, 0816539, 0816540, 0816541, 0816542, 0816543, 0816544, 0816545, 0816546, 0816548, 0816549, 0816550, 0816552, 1103826, 1103827, 1103828, 1103829, 1103830, 1103831, 1103832, 1103833, 1103834, 1177565, 1177567, 1177568, 1177569, 1177570, 1177571, 1177572, 1177573, 1177575, 1177576, 1177578, 1177579, 1177580, 1177581, 1177584, 1177585, 1177586, 1177587, 1177588, 1177589, 1177590, 1177591, 1177592, 1177593, 1177594, 1303849, 1303850, 1303851, 1303852, 1303853, 1303854, 1303855, 1303856, 1303857, 1303858, 1303859, 1303860, 1303861, 1303862, 1303863, 1457350, 1457351, 1457352, 1457353, 1457354, 1548854, 1548855, 1548856, 1548857, 1611609, 1611610, 1611611, 1611612, 1611613, 1611614, 1611615, 1611616, 1611617, 1611618, 1611619, 1611620, 1611621, 1705501, 1705502, 1705503, 1705504, 1705505, 1705506, 1705507, 1705508, 1705509, 1705510, 1705511, 1705512, 1705513, 1807587, 1807589, 1807591, 1807592, 1807593, 1807594, 1807595, 1824050, 1824051, 1824052, 1824054, 1845723, 1845724… Full codes in the FDA record	2,774 devices
Z-0021-2022	OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.; a. Item Number (Device Identifier; Serial number(s)): 02-012-35-0009 (10885862001641; 1678465, 1678471, 1678474, 1678481, 1957753, 2006036, 2006037, 2013812, 2043308, 2092688, 2554898, 2573058, 4705904); 02-012-35-0011 (10885862001658; 1678302, 1678309, 1678312, 1963089, 2019801, 2104502, 2104504, 2363227, 2666629, 3809531, 3809537, 4760880); 02-012-35-0013 (10885862001665; 1678446, 1678450, 2092581, 2092584, 2523130); 02-012-35-0015 (10885862001672; 1677680); 02-012-35-1009 (10885862001689; 1393427, 1393428, 1393429, 1393430, 1393431, 1393432, 1393433, 1393435, 1393436, 1393437, 1393438, 1393439, 1393440, 1393441, 1398561, 1398562, 1398563, 1398564, 1398568, 1398569, 1398573, 1398575, 1398578, 1398579, 1398580, 1398581, 1398582, 1398583, 1398584, 1398586, 1398587, 1398588, 1398589, 1398590, 1469287, 1469288, 1469289, 1469290, 1469291, 1469292, 1469293, 1469294, 1469296, 1472031, 1472032, 1472033, 1472034, 1472035, 1472038, 1472040, 1472042, 1472043, 1472044, 1472046, 1472047, 1486523, 1486525, 1486526, 1486527, 1486528, 1486529, 1486530, 1486531, 1486533, 1486534, 1486536, 1486537, 1486538, 1486539, 1486541, 1486542, 1486546, 1486548, 1486549, 1486550, 1486551, 1486552, 1491788, 1491789, 1491790, 1634088, 1634089, 1634090, 1634091, 1634092, 1634095, 1634097, 1736119, 1736121, 1736122, 1736123, 1736124, 1736125, 1736126, 1736127, 1736129, 1736130, 1736132, 1736133, 1736134, 1736135, 1736136, 1736137, 1736138, 1736140, 1736142, 1736143, 1736144, 1736145, 1736146, 1764587, 1764588, 1764589, 1764590, 1764592, 1764593, 1764596, 1764598, 1764599, 1764600, 1764601, 1764602, 1764604, 1764605, 1764606, 1767006, 1767007, 1767008, 1767009, 1767010, 1767011, 1767012, 1767013, 1767015, 1767016, 1767017, 1767018, 1767020, 1767022, 1767024, 1767025, 1767026, 1767027, 1767028, 1767029, 1767030, 1767031, 1850578, 1850579, 1850580, 1850581, 1850582, 1850583, 1850584, 1853045, 1853047, 1853048, 1853049, 1853050, 1853051, 1853220, 1853221, 1853222, 1853224, 1853226, 1853227, 1853229, 1853231, 1853232, 1853233, 1876767, 1876768, 1876772, 1876774, 1876775, 1888268, 1888270, 1888271, 1888272, 1888273, 1888274, 1888275, 1888276, 1888277, 1888278, 1888279, 1888282, 1888283, 1888284, 1888285, 1888286, 1888522, 1888523, 1888525, 1888526, 1888527, 1888530, 1888532, 1938613, 1938614, 1938615, 1938616, 1938618, 1938620, 1938622, 1938624, 1938625, 1938626, 1938627, 1938629, 1938630, 1938632, 1938634, 1941660, 1941661, 1941662, 1941664, 1941667, 1941668, 1941669, 1941670, 1941671, 1941674, 1941675, 1941676, 1941677, 1941679, 1941680, 1941681, 1941682, 1941683, 1941684, 1941686, 1941687, 2023267, 2023268, 2023269, 2023270, 2023273, 2023274, 2023276, 2036804, 2036805, 2036807, 2036808, 2036809, 2036810, 2036811, 2036812, 2036813, 2036814, 2036815, 2036816, 2036817, 2036818, 2036819, 2036820, 2036821, 2036822, 2036823, 2036825, 2036826, 2036829, 2036830, 2036832, 2036833, 2077388, 2077389, 2077390, 2077391, 2077392, 2077395, 2077396, 2077397, 2097467, 2097468, 2097469, 2097470, 2097471, 2097472, 2115480, 2115481, 2115483, 2115485, 2115486, 2115487, 2115489, 2115490, 2115493, 2115494, 2115496, 2115497, 2115498, 2143969, 2143970, 2143971, 2143972, 2143975, 2143976, 2143977, 2143978, 2143979, 2143980, 2143981, 2143983, 2143985, 2143988, 2256447, 2256449, 2256450, 2256452, 2256453, 2256454, 2256455, 2286050, 2286051, 2286053, 2286054, 2286055, 2286056, 2286058, 2286059, 2286060, 2286061, 2286064, 2286067, 2286068, 2286070, 2286072, 2286073, 2286075, 2286076, 2286077, 2286078, 2286079, 2286080, 2286081, 2286082, 2286083, 2286084, 2286085, 2286086, 2286088, 2332541, 2332542, 2332543, 2332544, 2332545, 2332546, 2332547, 2332548, 2332549, 2332550, 2332551, 2332554, 2332556, 2332557, 2332558, 2332559, 2332560, 2403623, 2403624, 2403625, 2403627, 2403630, 2403631, 2403636, 2403637, 2403638, 2403641, 2419071, 2419072, 2419073, 2419074, 2419075, 2419076, 2419077, 2419078, 2419079, 2419080, 2419082, 2419083, 2419088, 2419089, 2419091, 2419092, 2419096, 2419097, 2419099, 2419100, 2419101, 2419102, 2419103, 2419104, 2419105, 2419106, 2419108, 2419109, 2473927, 2473928, 2473930, 2473931, 2473932, 2473933, 2473935, 2473936, 2473937, 2473938, 2473939, 2473940, 2473941, 2473942, 2473944, 2491200, 2491201, 2491202, 2491204, 2491206, 2491207, 2491209, 2491210, 2491211, 2491212, 2491213, 2491215, 2491217, 2491218, 2491219, 2515836, 2515837, 2515838, 2515839, 2515840, 2515841, 2515842, 2515843, 2515845, 2515846, 2515848, 2515849, 2515850, 2515851, 2515852, 2515854, 2515855, 2542277, 2542278, 2542279, 2542280, 2542282, 2542283, 2542284, 2542285, 2542287, 2542288, 2542289, 2542290, 2542293, 2542295, 2542296, 2556889, 2556891, 2556892, 2556895, 2556896, 2556899, 2556900, 2556901, 2556902, 2556903, 2556906, 2619366, 2619367, 2619368, 2619369, 2619370, 2619371, 2619372, 2619373, 2619374, 2619375, 2619376, 2619377, 2666888, 2666889, 2666890, 2666891, 2666892, 2666893, 2666894, 2666895, 2694523, 2694524, 2694525, 2694526, 2694527, 2694528, 2694529, 2694530, 2694531, 2694532, 2694533, 2694534, 2694535, 2694537, 2694538, 2694539, 2694540, 2694541, 2754577, 2754578, 2754579, 2754580, 2754581, 2754582, 2754583, 2754584, 2754585, 2754586, 2797193, 2797194, 2797195, 2797196, 2797197, 2797198, 2797199, 2797200, 2797201, 2797202, 2877620, 2877621, 2877622, 2877623, 2877624, 2877625, 2877626, 2877627, 2877628, 2877630, 2877631, 2877632, 2877633, 2877634, 2877635, 2877637, 2877638, 2916621, 2916622, 2916623, 2916624, 2916625, 2916626, 2916627, 2916628, 2916629, 2916630, 2916631, 2916632, 2916633, 2916634, 2916635, 2916636, 2916637, 2916638, 2916639, 2916640, 2963067, 2963068, 2963069, 2963070, 2963072, 2963073, 2963074, 2963075, 2963076, 2968605, 2968606, 2968607, 2968608, 2968609, 2968610, 2968611, 2968612, 2968613, 2968614, 3001011, 3001012, 3001013, 3001014, 3001015, 3001016, 3001017, 3001018, 3001019, 3001020, 3001021, 3001022, 3001023, 3001024, 3001026, 3001027, 3001028, 3001029, 3565040, 3565041, 3565042, 3565043, 3565044, 3565045, 3565046, 3565047, 3565048, 3565049, 3565050, 3565051, 3565052, 3565053, 3565054, 3565055, 3565056, 3565057, 3565058, 3565059, 3592679, 3592680, 3592681, 3592682, 3592683, 3592684, 3592685, 3592686, 3592687, 3592688, 3592689, 3592690, 3592691, 3592692, 3592693, 3592694, 3592695, 3592696, 3592697, 3592698, 3617676, 3617678, 3617679, 3617680, 3617683, 3617684, 3617685, 3617686, 3617687, 3617688, 3617690, 3617691, 3617693, 3617695, 3637912, 3637913, 3637914, 3637915, 3637916, 3637917, 3637920, 3637921, 3637922, 3637923, 3637924, 3637925, 3637926, 3637927, 3637928, 3637929, 3637930, 3637931, 3701074, 3701075, 3701077, 3701080, 3701081, 3701082, 3701083, 3701084, 3701086, 3701087, 3716334, 3716335, 3716337, 3716338, 3731148, 3731149, 3731150, 3731151, 3731153, 3731154, 3731155, 3731156, 3731157, 3731158, 3731159, 3731160, 3731161, 3731162, 3731163, 3731164, 3731165, 3731166, 3731167, 3761378, 3761379, 3761380, 3761381, 3761382, 3761383, 3761384, 3761385, 3761386, 3761387, 3761388, 3761389, 3761390, 3761391, 3761392, 3761393, 3761394, 3761395, 3761396, 3761397, 3803104, 3803105, 3803106, 3803107, 3803108, 3803109, 3803110, 3803111, 3803112, 3803113, 3814603, 3814604, 3814605, 3814606, 3814607, 3814608, 3814610, 3814611, 3814612, 3814613, 3814614, 3814615, 3814616, 3814617, 3814618, 3814619, 3814620, 3814621, 3814622, 3821135, 3821137, 3821138, 3821139, 3821140, 3821141, 3821142, 3821143, 3821144, 3821146, 3821147, 3821148, 3821149, 3821150, 3821151, 3821152, 3821153, 3821154, 3847705, 3847706, 3847707, 3847708, 3847709, 3847710, 3847711, 3847712, 3847713, 3847715, 3847716, 3847718, 3847719, 3847720, 3847721, 3847722, 3847723, 3903161, 3903162, 3903163, 3903165, 3903166, 3903167, 3903169, 3903170, 3903171, 3903172, 3903173, 3903174, 3903175, 3903176, 3903178, 3903179, 3903181, 3903182, 3903183, 3903184, 3903185, 3903186, 3903187, 3903188, 3903190, 3903191, 3903192, 3903193, 3903195, 3903196, 3903197, 3903198, 3903199, 3970767, 3970768, 3970769, 3970770, 3970771, 3970772, 3970773, 3970774, 3970775, 3970776, 3970777, 3970778, 3970779, 3970781, 3970782, 3970783, 3970784, 3970785, 3970786, 3970787, 3970788, 3970789, 3970790, 4023709, 4023710, 4023711, 4023712, 4023714, 4023715, 4023716, 4023717, 4023718, 4023719, 4023720, 4023721, 4023722, 4023723, 4023724, 4023726, 4023727, 4023728, 4083658, 4083659, 4083660, 4083662, 4083663, 4083664, 4083665, 4083666, 4083667, 4083668, 4083669, 4083670, 4083671, 4083672, 4083673, 4083674, 4083675, 4083676, 4083677, 4185393, 4185394, 4185395, 4185396, 4185398, 4185399, 4185401, 4185402, 4185403, 4185405, 4185406, 4185407, 4185408, 4185409, 4185411, 4185412, 4198702, 4198703, 4198704, 4198705, 4198706, 4198709, 4198710, 4198711, 4205312, 4205315, 4205316, 4205317, 4205318, 4205319, 4205320, 4205321, 4223205, 4223206, 4223207, 4223209, 4223210, 4223211, 4223212, 4223214, 4223216, 4223217, 4223218, 4223220, 4223222, 4223223, 4366350, 4366351, 4366352, 4366354, 4366355, 4366356, 4366358, 4366359, 4366360, 4366361, 4366362, 4366363, 4366364, 4366365, 4366366, 4366367, 4366368, 4366369, 4443376, 4443377, 4443378, 4443379, 4443380, 4443381, 4443382, 4443384, 4443385, 4443386, 4443387, 4443388, 4443389, 4443390, 4443391, 4443392, 4443393, 4443394, 4443395, 4459167, 4459168, 4459169, 4459170, 4459172, 4459173, 4459174, 4459175, 4459176, 4459177, 4459178, 4459179, 4459180, 4459181, 4459182, 4459183, 4459184, 4459185, 4459186, 4498030, 4498031, 4498032, 4498033, 4498034, 4498035, 4498037, 4498038, 4498039, 4498040, 4498041, 4498042, 4498043, 4498044, 4498045, 4498046, 4498047, 4690095, 4690096, 4690097, 4690099, 4690100, 4690101, 4690102, 4690103, 4690104, 4690105, 4690106, 4690107, 4690108, 4690109, 4690110, 4690111, 4690112, 4690113, 4690114, 4709600, 4709602, 4709603, 4709604, 4709605, 4709608, 4709609, 4709614, 4709616, 4709618, 4709619, 4717590, 4717591, 4717592, 4717593, 4717594, 4717595, 4717596, 4717597, 4717599, 4717601, 4717602, 4717603, 4717604, 4717605, 4717606, 4717607, 4717608, 4717609, 4769228, 4769230, 4769231, 4769233, 4769236, 4769237, 4769242, 4769244, 4769246, 4807705, 4807706, 4807709, 4807710, 4807712, 4807714, 4807718, 4807719, 4807720, 4807721, 4807722, 4857473, 4857474, 4857476, 4857478, 4857480, 4857481, 4857482, 4857484, 4857485, 4857486, 4857487, 4857488, 4857489, 4857490, 4857491, 4857492, 4905218, 4905219, 4905220, 4905221, 4905222, 4905223, 4905224, 4905226, 4905228, 4905229, 4905230, 4905231, 4905232, 4905233, 4905234, 4905235, 4905237, 4919043, 4919044, 4919045, 4919046, 4919047, 4919048, 4919049, 4919050, 4919051, 4919052, 4919053, 4919054, 4919055, 4919056, 4919057, 4919058, 4919059, 4919060, 4919061, 4919062, 4919063, 4919064, 4919065, 4919066, 4919067, 4919068, 4919069, 4919070, 4919071, 4919072, 4919073, 4919074, 4919076, 4919077, 5199654, 5199655, 5199656, 5199658, 5199659, 5199662, 5199664, 5199665, 5199666, 5199667, 5199670, 5263388, 5263389, 5263390, 5263391, 5263394, 5263396, 5263398, 5263399, 5263400, 5263401, 5263403, 5263406, 5263407, 5263408, 5263409, 5263410, 5263413, 5263414, 5263415, 5263416, 5838383, 5838384, 5838385, 5838387, 5838389, 5838390, 5838391, 5838394, 5915272, 5915273, 5915276, 5915277, 5915278, 5930747, 5930748, 5930749, 5930751, 5930754, 5930755, 5930756, 6015750… Full codes in the FDA record	109,787 devices
Z-0022-2022	OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.; a. Item Number (Device Identifier; Serial number(s)): 900-06-18 (10885862100375; 1667962, 1667963); 900-06-20 (10885862100382; 1667796, 1667797); 900-06-22(10885862100399; 1667744, 1667745); 900-08-18 (10885862100405; 1667794, 1667795); 900-08-20 (10885862100412; 1667929, 1667930); 900-08-22 (10885862100429; 1667879, 1667880); b. Item Number (Device Identifier; Serial number(s)): 900-23-02 (10885862100863; 0899804, 0899805, 0899806, 0899807); 900-23-03 (10885862100870; 0900400, 0900401, 0900402, 0900403); 900-23-04 (10885862100887; 0900408, 0900409, 0900410, 0900411, 0900412); 900-23-05 (10885862100894; 0900413, 0900414, 0900415, 0900416); 900-23-06 (10885862100900; 0900404, 0900405, 0900406, 0900407); 900-30-11 (10885862101068; 0565754, 0565755); 900-30-13 (10885862101075; 0565756, 0565757); c. Item Number (Device Identifier; Serial number(s)): 900-33-09 (10885862101082; 1822113, 1822114); 900-33-11 (10885862101099; 1822115, 1822116)	41 devices
Z-0023-2022	TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.; a. Item Number (Device Identifier; Serial number(s)): 02-022-47-1009 (10885862306067; 4904358, 4904362, 4904363, 4904365, 5103012, 5132420, 5132432, 5186119, 5186125, 5186128, 5220427, 5220428); 02-022-47-1010 (10885862306074; 5054265, 5054269, 5054272, 5058395, 5058402, 5063328, 5063330, 5063335, 5063336, 5143808, 5143812); 02-022-47-1011 (10885862306081; 4715514, 4849121, 5101155, 5101164, 5108302, 5108315); 02-022-47-1012 (10885862306098, 5059598, 5059599, 5059601, 5073330, 5073334, 5073349, 5073352, 5073359, 5073378); 02-022-47-1013 (10885862306104; 4758320, 4758326, 4904379, 4904391, 5101413, 5153301, 5153309, 5153317, 5174543, 5174555); 02-022-47-1015 (10885862306128; 4904313, 4904317, 4904331, 5103330, 5124929, 5217018); 02-022-47-1509 (10885862306142; 5036961, 5036979, 5036982, 5058640, 5058655, 5058656, 5058657, 5101225, 5101226, 5101229, 5101231, 5101232, 5101238, 5168416, 5168417, 5168422, S235767); 02-022-47-1510 (10885862306159; 5085658, 5085662, 5085668, 5085681, 5085682, 5085705, 5085707, 5085718, 5085721, 5085722, 5085728, 5148139, 5148140, 5148147, 5230312, 5230322, 5390682); 02-022-47-1511 (10885862306166; 4998108, 4998112, 4998120, 4998128, 4998131, 4998133, 4998138, 5010573, 5010577, 5010578, 5063133, 5152788, 5152794, 5254482); 02-022-47-1512 (10885862306173; 5057888, 5057891, 5057895, 5057897, 5057926, 5128943, 5128946, 5174523, 5174535, 5174541, 5373484, 5373486); 02-022-47-1513 (10885862306180; 5036901, 5036902, 5036906, 5036935, 5091477, 5155207, 5254434); 02-022-47-1515 (10885862306258; 5035052, 5035055, 5035056, 5148160); 02-022-47-1517 (10885862306265; 5174515); 02-022-47-2009 (10885862306272; 4751940, 4751944, 4751946, 4751947, 4751949, 4751950, 4773516, 4773517, 4773518, 4773521, 4773522, 4773523, 4773526, 4773527, 4920753, 4920754, 4920755, 4920756, 4920758, 4920759, 4920762, 5069996, 5069998, 5069999, 5070000, 5070001, 5070002, 5070003, 5070005, 5070006, 5070007, 5070012, 5070017, 5070019, 5119730, 5119733, 5119734, 5119735, 5119737, 5119739, 5119740, 5119743, 5119746, 5119749, 5221997, 5222000, 5222001, 5222004, 5222005, 5222007, 5222009, 5222012, 5222013, 5222016, 5222017, 5222018, 5222022, 5222024, 5222026, 5222029, 5222030, 5222031, 5222033, 5222034, 5222036, 6943269, S044753, S044758, S044761, S044762, S044763, S044764, S044767, S044768, S064697, S064698, S064699, S078054, S078056, S078057, S078062, S078063, S078066, S078067, S078069, S078072, S078073, S078078, S078080, S078081, S078082, S078087, S078097, S078101, S078104, S078107, S246601, S246616, Z056123, Z056124, Z063902, Z063903, Z069601, Z069603); 02-022-47-2010 (10885862311344; 5054239, 5054242, 5054244, 5054245, 5054247, 5056080, 5056082, 5056085, 5056086, 5056087, 5056089, 5056092, 5056093, 5056094, 5056098, 5056101, 5056102, 5056103, 5066380, 5066381, 5066385, 5066396, 5066397, 5066398, 5119885, 5119889, 5119890, 5119894, 5217323, 5217324, 5217325, 5217326, 5217327, 5217329, 5217332, 5217334, S084971, S234331); 02-022-47-2011 (10885862306289; 4684423, 4684424, 4684425, 4684426, 4684428, 4684429, 4718053, 4718056, 4718060, 4718061, 4773399, 4773400, 4773403, 4920741, 4920745, 4920746, 4920750, 4920751, 5101186, 5101192, 5101194, 5101197, 5101199, 5101202, 5130146, 5130147, 5130150, 5130154, 5130162, 5130163, 5130165, 5130168, 5130169, 5130172, 5130176, 5220466, 5220468, 5220470, 5220475, 5220477, 5220479, 5220488, 5220495, S092853, Z053639); 02-022-47-2012 (10885862311429; 5053846, 5053852, 5053853, 5053858, 5053859, 5053861, 5053864, 5053869, 5053871, 5053879, 5053883, 5053884, 5070103, 5070106, 5070107, 5070108, 5070114, 5070123, 5070129, 5070132, 5070134); 02-022-47-2013 (10885862306296; 4684432, 4684435, 4684437, 4684438, 4684441, 4684443, 4753038, 4753048, 4900078, 4900079, 4900083, 4900090, 4900093, 5103469, 5103470, 5103475, 5103476, 5103480, 5103483, 5103485, 5119804, 5119806, 5119808, 5119812, 5119815, 5119819, 5119820, 5119825, 5119832, 5219855, 5219858, 5219859, 5219862, 5219867, 5219869, S221489); 02-022-47-2015 (10885862306302; 4684444, 4684446, 4684447, 4684449, 4684453, 4765784, 4899827, 4899830, 4899833, 4899834, 5064301, 5064304, 5064305, 5064308, 5064314, 5064317, 5129010, 5129019, 5129021, 5129024, 5129028, 5129030, 5220184, 5220189, S203101); 02-022-47-2017 (10885862306319; 5065369, 5065407); 02-022-47-2509 (10885862306326; 4684399, 4684400, 4684401, 4684403, 4684404, 4765817, 4765819, 4765820, 4765822, 4765823, 4765825, 4765826, 4900035, 4900036, 4900037, 4900038, 4900042, 4900043, 4900044, 4900045, 4916904, 4916905, 4916907, 4916908, 4916909, 4916910, 4916911, 4916912, 4916913, 4916914, 4916915, 5042988, 5042991, 5042992, 5042993, 5042995, 5042996, 5042998, 5043000, 5043002, 5043003, 5043007, 5043010, 5043012, 5063223, 5063225, 5063226, 5063229, 5063231, 5063232, 5063233, 5063234, 5209024, 5209026, 5209029, 5209030, 5209036, 5209040, 5209043, 5209045, 5209047, 5209053, 5209054, 5209055, 5209056, 5209058, 5209061, 5209062, 5209063, 5209068, S050046, S050057, S050058, S050059, S077842, S077847, S077854, S077855, S077856, S077867); 02-022-47-2510 (10885862311351; 5054687, 5054688, 5054691, 5054692, 5054693, 5054694, 5054695, 5054696, 5054698, 5054699, 5054702, 5054709, 5054710, 5054713, 5054716, 5054718, 5054724, 5054729, 5054730, 5054732, 5054735, 5054738, 5054740, 5054741, 5054742, 5054745, 5054748, 5054749, 5054750, 5054754, 5054762, 5054763, 5054764, 5054766, 5054768, 5054770, 5054772, 5054773, 5054774, 5054775, 5228152, 5228156, 5228157, 5228161, 5228164, S085427); 02-022-47-2511 (10885862306333; 4760673, 4760674, 4760675, 4760681, 4760684, 4899700, 4899702, 4899705, 4899709, 4899712, 4899713, 4899716, 4899720, 4899721, 4899722, 5065217, 5065218, 5065222, 5065223, 5065225, 5065229, 5065230, 5065232, 5065235, 5095042, 5095047, 5095048, 5095049, 5095051, 5095054, 5168403, 5168406, 5168409, 5168410, 5220501, 5220512, S122376, Z055885); 02-022-47-2512 (10885862311436; 5055145, 5055147, 5055152, 5055158, 5055159, 5055162, 5055165, 5055166, 5055171, 5055173, 5055176, 5055184, 5055195, 5055197, 5055199, 5055201, 5055204, 5055208, 5070443, 5095230, 5219872, 5219874, 5219880); 02-022-47-2513 (; 4764989, 4764990, 4764991, 4764993, 4764995, 4764997, 4899797, 4899798, 4899801, 4899813, 4899815, 5092625, 5092628, 5092635, 5092650, 5092657, 5092658, 5168992, 5169002, 5169006, 5169016, 5169022, Z055962); 02-022-47-2515 (10885862306357; 4753030, 4753032, 4753036, 4899985, 5094316, 5094323, 5094325, 5094350, 5094353, 5220069, 5220081); 02-022-47-2517 (10885862306364; 5108067, 5136880); 02-022-47-3009 (10885862306371; 4726122, 4726123, 4726128, 4726131, 4726132, 4726133, 4744267, 4744271, 4744272, 4744274, 4744276, 4773359, 4773360, 4773361, 4773362, 4773363, 4773364, 4773365, 4773368, 4773369, 4773370, 4929478, 4929480, 4929481, 4929482, 4929484, 4929487, 4929489, 4929498, 4929499, 4929501, 4933581, 4933582, 4933583, 4933585, 4933587, 4933589, 5042636, 5042637, 5042638, 5042640, 5042642, 5042644, 5042645, 5042646, 5042647, 5042648, 5042649, 5042651, 5042652, 5042653, 5042654, 5042658, 5116916, 5116917, 5116918, 5116920, 5116921, 5116922, 5116923, 5116924, 5116925, 5116926, 5116927, 5116928, 5116929, 5116930, 5116932, 5116933, 5116934, 5116935, 5116936, 5116937, 5116938, 5228507, 5228509, 5228510, 5228511, 5228512, 5228513, 5228514, 5228517, 5228518, 5228519, 5228520, 5228521, 5228523, 5228525, 5228528, 5228529, 5228530, 5228531, 5228534, 5228536, 5228537, 5228539, 5228543, 5228544, 5228545, 5228549, 5228550, 6943911, 6943915, S038177, S038178, S038179, S038180, S038181, S038182, S038183, S038184, S038185, S038187, S038188, S038190, S038191, S038192, S038193, S038194, S038195, S045557, S045558, S045559, S045560, S045561, S045562, S045563, S045564, S045567, S045569, S045570, S045571, S045572, S045573, S045575, S053122, S053123, S053126, S053128, S053130, S053131, S058214, S058215, S058216, S058217, S058219, S058221, S058222, S058225, S058226, S058227, S058231, S064732, S064733, S064734, S064735, S064736, S064737, S064738, S064740, S064741, S064742, S064743, S064745, S064746, S064748, S064749, S064751, S077336, S077339, S077340, S077341, S077344, S077345, S077347, S077348, S077355, S077356, S077357, S077358, S077359, S077360, S077365, S077367, S077368, S077371, S077372, S077373, S077375, S077376, S077377, S077378, S077380, S077382, S077384, S077388, S077389, S077394, S077395, S077399, S077400, S077402, S077403, S077404, S077405, S077407, S077408, S077409, S077411, S215347, S215354, S250290, S250298, S250302, S250325, S250326, S250328, Z052263, Z052267, Z052269, Z052270, Z052275, Z052276, Z054212, Z054214, Z054216, Z054217, Z054218, Z054220, Z074561); 02-022-47-3010 (10885862311368; 5055215, 5055216, 5055221, 5055224, 5055226, 5055227, 5055230, 5055231, 5055236, 5055240, 5055241, 5055242, 5055246, 5055248, 5055252, 5055253, 5055255, 5055257, 5055259, 5067757, 5067758, 5067759, 5067760, 5067762, 5067765, 5067767, 5101240, 5101241, 5101242, 5101243, 5101244, 5101247, 5101248, 5101249, 5101250, 5101252, 5101255, 5101256, 5101257, 5148128, 5148129, 5148130, 5148134, 5228033, 5228034, 5228035, 5228038, 5228039, 5228042, 5228043, 5228044, 5228046, 5228047, 5228048, 5228051, 5228053, S079073, S079075, S079076, S079081, S079099, S079101, S079110, S079112, Z064021, Z066150); 02-022-47-3011 (10885862306388; 4726170, 4726171, 4726172, 4726173, 4726174, 4726176, 4726179, 4726180, 4737852, 4737854, 4737855, 4737856, 4737857, 4737859, 4737860, 4737862, 4850847, 4850850, 4850852, 4850857, 4850858, 4904813, 4904814, 4904819, 4904820, 4904822, 5047342, 5047343, 5047344, 5047345, 5047350, 5047351, 5047353, 5047355, 5047357, 5047360, 5047362, 5047363, 5047366, 5059661, 5059662, 5059663, 5059664, 5059665, 5059668, 5059671, 5228551, 5228553, 5228554, 5228555, 5228556, 5228558, 5228563, 5228565, 5228568, 5228569, 5228570, 5228572, 5228573, 5228579, 5228580, 5228581, 5228584, 5228585, 5228588, 5228589, 5228590, 5228593, 5228595, 5228596, 5228597, 5228598, S064970, S064974, S064976, S064981, S077688, S077689, S077693, S077694, S077699, S077711, S077712, S077714, S221061, Z053428, Z053429, Z069567); 02-022-47-3012 (10885862311443; 5054118, 5054124, 5054128, 5057851, 5057855, 5057859, 5057860, 5057865, 5057866, 5057869, 5067138, 5067141, 5067142, 5067147, 5067152, 5067156, 5116889, 5116894, 5228019, 5228021); 02-022-47-3013 (10885862306395; 4737919, 4737920, 4737921, 4737922, 4737923, 4737924, 4737927, 4737929, 4737930, 4744217, 4744220, 4744222, 4744224, 4744227, 4744228, 4901572, 4901577, 4901589, 4901590, 4901594, 4901595, 5065140, 5065145, 5065155, 5065157, 5065162, 5065163, 5065165, 5065167, 5065170, 5065175, 5117017, 5117018, 5117019, 5117021, 5117022, 5117024, 5117030, 5229175, 5229177, 5229178, 5229179, 5229181, 5229182, 5229185, 5229186, 5229187, 5229189, 5229190, 5229191, 5229192, 5229193, 5229194, 5229196, 5229198, 5229200, 5229201, 5229204, S203756, S203767, S203770, X7098542); 02-022-47-3015 (10885862306401; 4723532, 4723533, 4723534, 4723535, 4723536, 4723537, 4723540, 4723541, 4760334, 4901622, 4901623, 4901630, 4901640, 4901643, 5075846, 5075855, 5075861, 5116876, 5116880, 5116881, 5116884, 5116886, 5168725, 5168726, 5168732, 5168733, 5168749, 5168750, 5230788, 5230790, 5230798, S028322, S028332); 02-022-47-3509 (10885862306425; 4684457, 4684459, 4684462, 4684463, 4684464, 4684465, 4684466, 4760686, 4760689, 4760690, 4760692, 4760693, 4760694, 4760695, 4760696, 4901525, 4901526, 4901527, 4901532, 4901533, 4901534, 4901535, 4901536, 4901537, 4901540, 4901541, 4901542, 4901543, 4901546, 4901547, 4901548, 5064275, 5064276, 5064277, 5064278, 5064279, 5064282, 5064283, 5064284, 5064289… Full codes in the FDA record	31,201 devices
Z-0024-2022	Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.; a. Item Number (Device Identifier; Serial number(s)): 350-21-01 (10885862276216; 4833710, 4833714, 4833715, 4833717, 4833723, 5188005, 5188007, 5188008, 5188009, 5188011, 5188013, 5188015, 5188017, 5188021, 5188022, 5188023, 5939820, 5939826, 5939831, 5939832, 5939833, 5939835, 5939836, 5939837, 5939838, 5939839, 5939840, 5939841, 5939842, 5939844, 5939845, 5939846, 6015553, 6015554, 6015556, 6015557, 6015560, 6015563, 6015566, 6015567, 6015569, 6396486, 6396489, 6396493, 6396495, 6396500, 6396504, 6396505, 6489379, 6489381, 6489382, 6489384, 6489386, 6606659, 6606667, 6606678, 6860126, 6860127, 6900582, 6900585, 6900588, Z060698, Z060703, Z060715, Z064072, Z064105, Z064107); 350-21-02 (10885862276223; 4536664, 4536665, 4536666, 4536668, 4536669, 4536670, 4536672, 4842955, 4842956, 4842957, 4842958, 4842959, 5184645, 5184647, 5184648, 5184649, 5184651, 5184652, 5184653, 5184654, 5184656, 5184657, 5184658, 5855814, 5855815, 5855816, 5855819, 5855820, 5855823, 5855824, 5855825, 5855826, 5855827, 5855828, 5855829, 5855830, 6240459, 6240461, 6240463, 6240464, 6240467, 6259881, 6259882, 6259884, 6259885, 6259888, 6356551, 6356552, 6356561, 6356562, 6356564, 6356566, 6356568, 6356569, 6356570, 6395847, 6395848, 6395852, 6395854, 6395855, 6395856, 6395858, 6395860, 6489055, 6489056, 6489059, 6489063, 6489065, 6489066, 6489069, 6489070, 6489071, 6489072, 6489073, 6583838, 6583839, 6583842, 6583843, 6583844, 6583845, 6583846, 6583849, 6583852, 6583853, 6583855, 6583857, 6730685, 6730688, 6730690, 6730696, 6730697, 6899729, 6899744, 6899751, Z068705, Z075029, Z075042); 350-21-03 (10885862276230; 4536738, 4536739, 4536740, 4536741, 4536742, 4536743, 4536745, 4536746, 4841023, 4841024, 4841025, 5184662, 5184663, 5184665, 5184666, 5184668, 5184669, 5184671, 5184672, 5184673, 5184674, 5184675, 5184678, 5184679, 5184680, 5221264, 5221265, 5221266, 5221267, 5221268, 5221269, 5221270, 5221272, 5221273, 5221274, 5221275, 5221276, 5940499, 5940500, 5940502, 5940507, 5940511, 5940516, 5940517, 5940518, 5940519, 5940520, 6039207, 6039208, 6039210, 6039212, 6039213, 6039214, 6039215, 6039218, 6039220, 6039221, 6039222, 6039223, 6039225, 6173447, 6173449, 6173450, 6173451, 6173452, 6173455, 6173456, 6173458, 6173459, 6173460, 6173462, 6173463, 6173464, 6173465, 6372717, 6372718, 6372719, 6372720, 6372721, 6372726, 6372727, 6372729, 6372730, 6372735, 6489128, 6489129, 6489131, 6489133, 6489134, 6489135, 6489136, 6489137, 6489145, 6489146, 6535721, 6535723, 6535724, 6535729, 6535730, 6535731, 6535732, 6535734, 6742242, 6742248, 6742249, 6742250, 6742251, 6742253, 6742255, 6742259, 6811600, 6811611, 6811612, 6900322, Z074962, Z074972, Z074984, Z075184); 350-21-04 (10885862276247; 4537204, 4537205, 4537206, 4537207, 4537212, 4750991, 5184539, 5184541, 5184543, 5184548, 5184550, 5184553, 5184554, 5184557, 5240718, 5240721, 5240727, 5240728, 5909332, 5909335, 5909337, 5909338, 5909344, 5909350, 5954808, 5954810, 5954815, 5954820, 6356463, 6356464, 6356466, 6356471, 6356472, 6356473, 6356477, 6489076, 6489081, 6489083, 6489093, 6758223, 6758226, 6758227, 6856945, 6856949, 6995782, Z068655); 350-21-11 (10885862276254; 4536710, 4536711, 4536714, 4536715, 4536716, 4536717, 4536718, 4704930, 4704938, 4704939, 4704940, 4704944, 4704945, 4704949, 4704951, 4704956, 4704957, 4787630, 4787631, 5184636, 5184639, 5184640, 5184643, 5231854, 5231855, 5231858, 5231860, 5969127, 5969128, 5969129, 5969132, 6356520, 6356523, 6489037, 6489045, 6489052); 350-21-12 (10885862276261; 4704789, 4771382, 4771383, 4771384, 4771387, 4771388, 5184684, 5184689, 5184690, 5184691, 5184697, 5184698, 5237420, 5237421, 5237422, 5237423, 5237424, 5237426, 5237430, 5237431, 5237432, 5939798, 5939801, 5939802, 5939803, 5939807, 5939810, 6356669, 6356670, 6356671, 6356672, 6356677, 6356680, 6356681, 6356683, 6356684, 6489360, 6489363, 6489365, 6489366, 6489369, 6489370, 6489372, 6598979, 6598980, 6598983, 6598985, 6843245, 6843247, 6843261, 6883796, Z058384, Z074986, Z074999); 350-21-13 (10885862276278; 4704790, 4771176, 4977232, 4977233, 4977235, 5181919, 5181921, 5181923, 5181926, 5181927, 5181931, 5181932, 5181934, 5222348, 5222349, 5222352, 5222355, 5222356, 5222357, 5222358, 5908535, 5908536, 5908537, 5908540, 5908541, 5908542, 5908544, 5908548, 5908549, 6061322, 6061327, 6323250, 6323261, 6395423, 6395424, 6395426, 6395428, 6488292, 6488297, 6488301, Z075109, Z075175); 350-21-14 (10885862276285; 4746009, 5184848, 5184851, 5184852, 5184853, 5184858, 5184860, 5184864, 5184865, 6143314, 6143323, 6143326, 6143329, 6143331, 6395394, 6395395, 6719894, Z076042); 350-21-21 (10885862276292; 4676330, 4676331, 4676332, 4676333, 4676334, 4676335, 4676336, 4676338, 4676345, 4676347, 4676351, 4676355, 5185107, 5185108, 5185110, 5185111, 5185113, 5185114, 5185117, 5185118, 5185119, 5245298, 5906409, 5906414, 5938419, 5938422, 5938424, 5938428, 6356532, 6356533, 6356537, 6356542, 6356549, 6486889, 6486890, 6486896, 6804245, 6900926); 350-21-22 (10885862276308; 4750965, 4771177, 5184866, 5184867, 5184870, 5184872, 5184873, 5184874, 5184878, 5184879, 5184880, 5184881, 5184883, 5876458, 5876461, 5876467, 6142807, 6142808, 6142811, 6142819, 6142825, 6411781, 6411784, 6428914, 6428917, 6428918, 6435219, 6435225, 6621519, 6621521, 6621524, 6621536, 6883664, 6883667, 6883671, 6959803, Z059779); 350-21-23 (10885862276315; 4771244, 4866126, 4866127, 4866129, 5172559, 5172560, 5172565, 5172566, 5172567, 5172569, 5172570, 5172572, 5172574, 5172577, 5172580, 5172581, 5172582, 5172583, 5172584, 5172588, 5172589, 5989847, 5989848, 5989849, 5989850, 5989853, 5989859, 5989861, 6408952, 6408954, 6408958, 6408959, 6408960, 6487891, 6487893, 6487895, 6487896, 6487897, 6487900, 6487902, 6487908, 6487909, 6644822, 6644825, 6644826, 6644831, 6644834, 6644835, 6644838, Z058458, Z058462, Z060686); 350-21-24 (10885862276322; 4536720, 4536721, 4536723, 4536724, 5185120, 5185127, 5185129, 5185132, 5185133, 5185134, 5185135, 5245294, 5245296, 5882353, 5882355, 5882358, 5882364, 5882365, 6142592, 6142601, 6142602, 6142605, 6142607, 6142608, 6396151, 6396156, 6851740, Z058435); 350-21-41 (10885862293213; 5181205, 5181206, 5181209, 5181210, 5181211, 5181212, 5181214, 5181215, 5181217, 5181218, 5181219, 5181222, 5954729, 5954730, 5954736, 5954745, 6409727, 6747749, 6747752, 6897935); 350-21-42 (10885862293220; 5184830, 5184831, 5184833, 5184837, 5184838, 5184839, 5184840, 5184844, 5184845, 5201342, 5201345, 5201349, 5909253, 5940479, 5940481, 5940482, 5940484, 5940487, 5940493, 5940495, 6143274, 6143276, 6143277, 6143282, 6143285, 6143286, 6143289, 6143292, 6396172, 6540417, 6540421, 6911569, Z059753); 350-21-43 (10885862293237; 5102165, 5102166, 5102171, 5102173, 5102174, 5102178, 5102179, 5102180, 5102183, 5230186, 5230190, 5230192, 5230196, 5230197, 5230199, 5230200, 5230203, 5912834, 5912837, 5912838, 5912840, 5912844, 5912846, 5912848, 6015723, 6015725, 6015728, 6395893, 6395900, 6571764, 6571775, 6860987, 6913035, Z077359); 350-21-44 (10885862293244; 5181165, 5181177, 5181178, 5967776, 5967781, 6325734, 6398023, 6424762, 6709425); 350-21-61 (10885862293374; 5185137, 5185147, 5909303); 350-21-62 (10885862293381; 6143359, 6143360, 6143368, 6143370, Z060582); 350-21-63 (10885862293398; 4733268, 5185157, 6487566); 350-21-64 (10885862293404; 5185168, 6143340, 6143348, 6488098); 350-22-01 (10885862276339; 4681920, 4681922, 4681923, 4681925, 4681927, 4681928, 4681930, 4681931, 4681932, 4681933, 4681934, 4681935, 4681937, 4681938, 4681940, 4681943, 4681945, 4681946, 4681948, 4681949, 5139951, 5139952, 5139953, 5139955, 5139956, 5139962, 5139963, 5139968, 5139970, 5139971, 5876391, 5876392, 5876393, 5876396, 5876398, 5876399, 5876403, 5876407, 5876412, 6127984, 6127985, 6127987, 6127993, 6127995, 6127997, 6128000, 6128003, 6395402, 6395406, 6395407, 6395410, 6395417, 6487092, 6487093, 6487094, 6487095, 6487097, 6487100, 6487102, 6487103, 6487106, 6487107, 6487108, 6487110, 6720137, 6720139, 6720142, 6720145, 6720146, 6720150, 6720152, 6720153, 6907877, 6907886, 6907887, 6907888, 6907892, 6907896, 6907899, 6907901, 6911587, 6911594, Z073322, Z073329); 350-22-02 (10885862276346, 4771234, 4771235, 4771236, 4771237, 4771238, 4771239, 4771240, 5181224, 5181225, 5181228, 5181229, 5181234, 5181235, 5181236, 5181237, 5181238, 5181239, 5181240, 5181241, 5181242, 5181244, 5245289, 5245290, 5245291, 5245292, 5245293, 5985462, 5985463, 5985464, 5985466, 5985468, 5985470, 5985471, 5985472, 5985473, 5985474, 5985475, 5985476, 5985477, 5985478, 5985480, 5985481, 6048026, 6048027, 6048028, 6048030, 6048031, 6067781, 6067782, 6067783, 6067785, 6067786, 6067787, 6067788, 6067790, 6067792, 6259896, 6259897, 6308445, 6308446, 6308447, 6308448, 6308451, 6308452, 6308454, 6308458, 6411977, 6411978, 6411979, 6411980, 6411981, 6411983, 6411984, 6411985, 6411989, 6434808, 6434811, 6434812, 6434813, 6434814, 6434816, 6434817, 6434818, 6434820, 6434821, 6434822, 6434823, 6434824, 6532890, 6532891, 6532895, 6532898, 6532899, 6532900, 6532902, 6532903, 6532904, 6532907, 6535639, 6535641, 6535643, 6535644, 6535645, 6535646, 6535649, 6535650, 6535651, 6535654, 6535657, 6758072, 6758073, 6758074, 6899905, 6899911, 6899914, 6899919, Z071104, Z071116, Z071136, Z076051); 350-22-03 (10885862276353; 4884296, 4884297, 4884298, 4884299, 5185183, 5185184, 5185187, 5185189, 5185190, 5185191, 5185192, 5185194, 5185195, 5185196, 5256071, 5256072, 5256073, 5256074, 5256075, 5256077, 5256078, 5256079, 5256080, 5938438, 5938439, 5938440, 5938441, 5938442, 5938447, 5938448, 5938451, 5938452, 5938453, 5938454, 5938456, 5938457, 5988014, 5988015, 5988016, 5988018, 5988019, 5988020, 5988022, 5988023, 5988025, 5988026, 5988027, 5988029, 5988030, 6252633, 6252634, 6252636, 6252638, 6252640, 6252641, 6285206, 6285207, 6285208, 6285210, 6285211, 6285212, 6285213, 6285215, 6340621, 6340630, 6340631, 6340632, 6340635, 6395438, 6395439, 6395440, 6395441, 6395444, 6395446, 6395451, 6395456, 6395457, 6482649, 6482650, 6482656, 6482662, 6482664, 6482665, 6509210, 6509214, 6509215, 6509216, 6509218, 6509219, 6509220, 6509223, 6509224, 6509227, 6683471, 6683474, 6683475, 6683477, 6683482, 6683485, 6683488, 6683492, 6718699, 6718707, 6718715, 6718716, 6852366, 6852367, 6852368, 6852375, 6852377, 6852379, 6853420, 6853427, 7010354, Z072696, Z073295); 350-22-04 (10885862276360; 5181310, 5181313, 5181314, 5181315, 5181317, 5181323, 5181327, 5262727, 5262729, 5262730, 5262731, 5262733, 5262735, 5262736, 5262737, 5907662, 5907666, 5907670, 5907671, 5907672, 5907673, 5907674, 5907676, 5967477, 5967482, 5967487, 5967488, 5967489, 5967491, 5967493, 5967494, 5967495, 6337400, 6337402, 6337406, 6337407, 6482499, 6502574, 6502576, 6502580, 6502586, 6502589, 6846082, 6846088, Z058442, Z058443, Z075357); 350-22-11 (10885862276377; 4703168, 4703171, 4703174, 4703177, 4703178, 4703179, 4703180, 4703183, 4703184, 4703187, 4703188, 4703190, 4703191, 4703192, 4703193, 4703194, 4703195, 4703196, 4703197, 4857844, 4857845, 4857846, 4857847, 5181328, 5181331, 5181336, 5181337, 5181338, 5181339, 5181341, 5181343, 5181345, 5954756, 5954758, 5954759, 5954761, 5954765, 6137105, 6137106, 6137115, 6137119, 6137121, 6372459, 6372468, 6372471, 6372474, 6372475, 6487131, 6487137, 6898086, Z075079); 350-22-12 (10885862276384; 4704788, 4771243, 5181347, 5181348, 5181349, 5181351, 5181352, 5181353, 5181354, 5181355, 5181356, 5181359, 5181360, 5181363, 5181364, 5193990, 5193991, 5193993, 5193995, 5193996, 5193997, 5193998, 5193999, 5194001, 5194002, 5194003, 5194004, 5882202, 5882208, 5882209, 5882210, 5882211, 5882212, 5882214, 5882215, 5882216, 5882218, 5882219, 5882282, 5882283, 5882284, 5882285, 5882286, 5882292, 5882295, 6356685, 6356691, 6356694, 6356695… Full codes in the FDA record	2,217 devices
Z-0025-2022	OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.; Item Number (Device Identifier; Serial number(s)): 264-21-09 (10885862068842; 0754387, 0754388, 0754390, 0754391, 0754392, 0754393, 0754394, 0754396, 0754397, 0754398, 0754399, 0754400, 0754401, 0754402, 0754403, 0754404, 0754405, 0754406, 0754407, 0754408, 0754409, 0754410, 0754411, 0754412, 0754413, 0754414, 0754415, 0754416, 0754417, 0754418, 0754419, 0754420, 0754421, 0754422, 0754423, 0754424, 0754425, 0754426, 0754427, 0782395, 0782396, 0782397, 0782398, 0782399, 0782400, 0782401, 0782402, 0782403, 0782404, 0782405, 0782406, 0782407, 0782408, 0782409, 0782410, 0782411, 0782412, 0782413, 0782414, 0782415, 0782416, 0782417, 0782418, 0782419, 0782420, 0782421, 0782422, 0782423, 0782424, 0782425, 0782426, 0782427, 0782428, 0782429, 0782430, 0782431, 0782432, 0782433, 0782434, 0782435, 0782436, 0782437, 0782438, 0782439, 0782440, 0782441, 0782442, 0862418, 0862420, 0862422, 0862424, 0862425, 0862426, 0862427, 0862428, 0862429, 0862430, 0862431, 0862432, 0862434, 0862435, 0862436, 0862437, 0862438, 0862439, 0862440, 0862441, 0862442, 0862443, 0862444, 0862445, 0862447, 0862448, 0862449, 0862450, 0862451, 0862452, 0862453, 0862454, 0862455, 0862456, 0862457, 0862458, 0862459, 0862460, 0862461, 0862462, 0862463, 0862464, 0862466, 0862468, 0862469, 0912159, 0912160, 0912168, 0912169, 0912171, 0912172, 0912175, 0912177, 0912178, 0912179, 0912180, 0912182, 0912187, 0912189, 0912192, 0912195, 0912197, 0912198, 0912201, 0912202, 0912203, 0912204, 0912205, 0912206, 0912207, 0912211, 0912215, 0912216, 0912218, 0912219, 0912220, 0912222, 0912223, 0912225, 0912226, 0912227, 0912228, 0912229, 0912230, 0912231, 0933159, 0933160, 0933161, 0933162, 0933163, 0933164, 0933165, 0933166, 0933167, 0933168, 0933169, 0933170, 0933171, 0933172, 0933173, 0933174, 0933175, 0933176, 0933177, 0933178, 0933180, 0933181, 0933184, 0933185, 1012978, 1012979, 1012980, 1012981, 1012982, 1012983, 1012984, 1012985, 1012986, 1012987, 1012988, 1012989, 1012990, 1012991, 1012992, 1012993, 1012994, 1012995, 1012996, 1012997, 1012998, 1012999, 1013000, 1013001, 1013002, 1013003, 1013004, 1013005, 1013006, 1013007, 1013008, 1013009, 1013010, 1013011, 1013012, 1013013, 1013014, 1013015, 1013016, 1013017, 1013018, 1013019, 1013020, 1013021, 1013022, 1013023, 1013024, 1013025, 1013026, 1013027, 1013028, 1013029, 1013030, 1087277, 1087278, 1087279, 1087280, 1087281, 1087282, 1087283, 1087284, 1087285, 1087286, 1087287, 1087288, 1087289, 1087290, 1087291, 1087292, 1087293, 1087294, 1087295, 1087296, 1087297, 1087298, 1087299, 1087300, 1087301, 1087302, 1087303, 1087304, 1087305, 1087306, 1087307, 1087308, 1087309, 1087310, 1087311, 1087312, 1087313, 1087314, 1087315, 1087316, 1087317, 1087318, 1087319, 1087320, 1087321, 1087322, 1087323, 1087324, 1087325, 1087326, 1087327, 1087328, 1087329, 1087330, 1087331, 1143864, 1143865, 1143866, 1143867, 1143868, 1143869, 1143870, 1143871, 1143872, 1143873, 1143874, 1143875, 1143876, 1143877, 1143878, 1143879, 1143880, 1143881, 1143883, 1143884, 1143885, 1143886, 1143887, 1143888, 1143889, 1143890, 1143891, 1143892, 1143893, 1143894, 1143895, 1143897, 1143898, 1143899, 1143900, 1143901, 1143902, 1143903, 1143904, 1143905, 1143906, 1143907, 1143908, 1143909, 1143910, 1143911, 1143912, 1262413, 1262414, 1262415, 1262416, 1262417, 1262418, 1262419, 1262420, 1262421, 1262422, 1262423, 1262427, 1262428, 1262429, 1262430, 1262431, 1262433, 1262434, 1262435, 1262436, 1262437, 1262439, 1262440, 1262441, 1262442, 1262443, 1262444, 1262445, 1262446, 1262447, 1262448, 1262450, 1262451, 1262452, 1262453, 1262454, 1262455, 1262456, 1262457, 1262458, 1262459, 1262460, 1262461, 1262462, 1262463, 1262464, 1262465, 1262466, 1264736, 1264737, 1264738, 1264739, 1264740, 1264741, 1264742, 1264743, 1264744, 1264745, 1264746, 1264747, 1264748, 1264749, 1264750, 1264751, 1264752, 1264753, 1264754, 1264755, 1264756, 1264757, 1264758, 1264759, 1264760, 1264761, 1264762, 1264763, 1264765, 1264766, 1264767, 1264768, 1264769, 1264770, 1264771, 1264772, 1264773, 1264774, 1264775, 1264776, 1264778, 1264780, 1264781, 1264782, 1264783, 1264784, 1264785, 1264786, 1264787, 1264788, 1391127, 1391128, 1391129, 1391130, 1391131, 1391132, 1391134, 1391135, 1391136, 1391137, 1391138, 1391139, 1391140, 1391141, 1391142, 1391143, 1391144, 1391145, 1415456, 1415457, 1415458, 1415459, 1415460, 1415461, 1415462, 1415464, 1415465, 1415466, 1415467, 1415468, 1415469, 1415470, 1415471, 1415472, 1415473, 1415474, 1415475, 1415476, 1415477, 1415478, 1415479, 1415480, 1415481, 1415482, 1415483, 1415484, 1415485, 1449449, 1449450, 1449451, 1449452, 1449453, 1449455, 1449456, 1449457, 1449458, 1449459, 1449460, 1449461, 1457735, 1457736, 1457737, 1457738, 1457739, 1457740, 1457741, 1462886, 1462887, 1462888, 1462889, 1462890, 1462891, 1462892, 1462893, 1462894, 1462895, 1475263, 1475264, 1475265, 1475266, 1475267, 1475269, 1475270, 1475271, 1494126, 1494127, 1494128, 1494129, 1494130, 1494131, 1494132, 1494133, 1494134, 1494135, 1494136, 1494137, 1494138, 1494139, 1532387, 1532388, 1532390, 1532391, 1532392, 1532393, 1532394, 1532395, 1532396, 1532397, 1532398, 1532399, 1532400, 1532401, 1532402, 1532403, 1532404, 1532405, 1532406, 1532407, 1532408, 1562405, 1562406, 1562407, 1562408, 1562409, 1562410, 1562414, 1562415, 1562416, 1562417, 1562418, 1562419, 1562420, 1562421, 1562422, 1562423, 1562424, 1562425, 1562426, 1604479, 1604480, 1604481, 1604482, 1604483, 1604484, 1604485, 1604486, 1604487, 1604488, 1604489, 1604490, 1604491, 1604492, 1604493, 1604494, 1604495, 1604497, 1604498, 1604499, 1604500, 1604501, 1604502, 1604503, 1604504, 1604505, 1604506, 1604507, 1604508, 1604509, 1604511, 1604512, 1604513, 1605548, 1605549, 1605550, 1605551, 1605552, 1605553, 1605554, 1605555, 1605556, 1605557, 1605558, 1605559, 1605560, 1605561, 1605562, 1605563, 1605564, 1605565, 1605566, 1605567, 1605568, 1605569, 1605570, 1605571, 1605572, 1649349, 1649350, 1649351, 1649352, 1649353, 1649354, 1649355, 1649356, 1649357, 1649358, 1649359, 1649360, 1649361, 1649362, 1649363, 1649364, 1649365, 1649366, 1649367, 1649368, 1649369, 1649370, 1649371, 1649372, 1649373, 1649374, 1649375, 1649376, 1649377, 1649378, 1687454, 1687455, 1687456, 1687457, 1687458, 1687459, 1687460, 1687461, 1687462, 1687463, 1687464, 1687465, 1687466, 1687467, 1687468, 1687469, 1687470, 1687471, 1687474, 1687475, 1687476, 1687477, 1687478, 1687479, 1687480, 1687481, 1687482, 1687484, 1687486, 1687487, 1687488, 1687489, 1689514, 1689515, 1689516, 1689517, 1689518, 1689519, 1689520, 1689521, 1689522, 1689523, 1689524, 1689525, 1689526, 1689527, 1689528, 1721357, 1721358, 1721359, 1721360, 1721361, 1721362, 1721363, 1721364, 1721365, 1721366, 1721367, 1721368, 1721369, 1721370, 1721371, 1721372, 1721373, 1721374, 1721375, 1721376, 1721377, 1721378, 1721379, 1721380, 1721381, 1721382, 1721383, 1721385, 1721386, 1721387, 1721388, 1734175, 1734176, 1734177, 1734178, 1734179, 1734180, 1734181, 1734182, 1734183, 1734184, 1734185, 1734186, 1734187, 1734188, 1734189, 1734190, 1734191, 1734192, 1734193, 1734194, 1734195, 1734196, 1734197, 1734198, 1734199, 1734200, 1734201, 1734202, 1734203, 1734204, 1862887, 1862888, 1862889, 1862890, 1862891, 1862893, 1862894, 1862895, 1862896, 1862897, 1862898, 1862899, 1862900, 1862901, 1862902, 1862903, 1862904, 1862905, 1862906, 1862907, 1862908, 1862909, 1862910, 1862911, 1862912, 1862913, 1862914, 1862915, 1862916, 1862917, 1862918, 1862919, 1862920, 1862921, 1862922, 1862923, 1862924, 1862925, 1862926, 1862927, 1944636, 1944637, 1944638, 1944639, 1944640, 1944641, 1944642, 1944643, 1944644, 1944645, 1944646, 1944647, 1944648, 1944649, 1944650, 1944651, 1944652, 1944653, 1944654, 1944655, 1944656, 1944657, 1944658, 1944659, 1944660, 1944661, 1944662, 1995923, 1995924, 1995925, 1995926, 1995927, 1995928, 1995929, 1995930, 1995931, 1995932, 1995933, 1995934, 2009334, 2009335, 2009336, 2009337, 2009338, 2009339, 2009340, 2009341, 2009342, 2009343, 2009344, 2009345, 2033013, 2033014, 2033015, 2033016, 2033018, 2033019, 2033020, 2033021, 2068996, 2068997, 2068998, 2069000, 2069001, 2069002, 2069003, 2069004, 2069005, 2069006, 2069007, 2069008, 2069009, 2069010, 2069011, 2069012, 2069013, 2069014, 2069015, 2069017, 2069018, 2069019, 2069021, 2069022, 2069023, 2069024, 2069025, 2182623, 2182625, 2182626, 2182627, 2182628, 2182630, 2182631, 2182634, 2182636, 2182637, 2182638, 2182639, 2182640, 2182641, 2182642, 2182643, 2182644, 2182645, 2182646, 2182647, 2354939, 2354940, 2354942, 2354943, 2354944, 2354945, 2354946, 2354947, 2354949, 2354950, 2354951, 2354952, 2354953, 2354954, 2354955, 2354956, 2354958, 2354960, 2354961, 2354962, 2354963, 2472577, 2472578, 2472579, 2472580, 2472581, 2472582, 2472583, 2472585, 2472586, 2472587, 2472588, 2472589, 2472590, 2472591, 2505824, 2505825, 2505826, 2505827, 2525096, 2525097, 2525099, 2525100, 2525101, 2525102, 2525103, 2525104, 2525105, 2525106, 2525107, 2525109, 2525112, 2525113, 2525114, 2787408, 2787409, 2787410, 2787411, 2787412, 2787413, 2787414, 2787415, 2787416, 2787417, 2787418, 2787419, 2787420, 2787421, 2787422, 2787423, 2787424, 2787425, 2787426, 2787427, 2787428, 2787429, 2787430, 2787431, 2787432, 2787433, 2787434, 2787437, 2870606, 2870607, 2870608, 2870609, 2870610, 2870611, 2870612, 2870613, 2870614, 2870615, 2870616, 2870617, 2870618, 2870619, 2870620, 2870621, 2870623, 2870624, 2870625, 2870626, 2870627, 2870628, 2870629, 2870630, 2870631, 2870632, 2870633, 2870634, 2870635, 3547769, 3547773, 3547774, 3547775, 3547776, 3547778, 3547779, 3547780, 3547782, 3547783, 3547784, 3547786, 3547787, 3547788, 3547789, 3547790, 3547793, 3547794, 3547795, 3547796, 3547798, 3661199, 3661200, 3661201, 3661202, 3661203, 3661204, 3661205, 3661206, 3661207, 3661208, 3692664, 3692665, 3692666, 3692667, 3692668, 3692672, 3692673, 3692674, 3692675, 3692676, 3741725, 3741726, 3741727, 3741728, 3741729, 3741730, 3741731, 3741732, 3741733, 3741734, 3971372, 3971374, 3971376, 3971378, 4093040, 4093041, 4093043, 4093044, 4093045, 4093046, 4093047, 4093048, 4093049, 4476362, 4476363, 4476364, 4476367, 4476368, 4476371, 4794018, 4794020, 4794021, 4794023, 4848662, 4848664, 4848665, 4848667, 4848670, 4848671, 4848672, 4848673, 4848674, 4848676, 4848677, 4848679); 264-21-11 (10885862068859; 0762174, 0762175, 0762176, 0762178, 0762179, 0762180, 0762181, 0762182, 0762183, 0762184, 0762185, 0762186, 0762187, 0762188, 0762189, 0762190, 0762191, 0762192, 0762193, 0762194, 0762195, 0762196, 0762197, 0762199, 0762200, 0762201, 0762202, 0762203, 0762204, 0762205, 0762206, 0762207, 0762208, 0762210, 0762211, 0762212, 0762213, 0762214, 0762215, 0762216, 0782293, 0782294, 0782295, 0782296, 0782297, 0782298, 0782299, 0782300, 0782301, 0782302, 0782303, 0782304, 0782305, 0782306, 0782307, 0782308, 0782309, 0782310, 0782311, 0782312, 0782313, 0782314, 0782315, 0782316, 0782317, 0782318, 0782319, 0782320, 0782321, 0782322, 0782323, 0782324, 0782325, 0782326, 0782327, 0782328, 0782329, 0782330, 0782331, 0782332, 0782333, 0782334, 0782335, 0782336, 0782337, 0782338, 0782339, 0782340, 0782341, 0782342, 0864278, 0864279, 0864280, 0864281, 0864282, 0864283, 0864285, 0864286, 0864287, 0864288, 0864290, 0864291, 0864292, 0864293, 0864294, 0864295, 0864297, 0864298, 0864299, 0864300, 0864301, 0864303, 0864304, 0864305, 0864306, 0864307, 0864309, 0864312, 0864313, 0864314, 0864316, 0864317, 0864319, 0864320, 0864321, 0864322, 0864323, 0864324, 0864326, 0864328, 0864330, 0922903, 0922904, 0922905, 0922914, 0922921, 0922922, 0922923, 0922925, 0922926, 0922930, 0922931, 0922932, 0922933, 0922934, 0922936, 0922937, 0922938, 0922940, 0922941, 0922942, 0922943, 0922944, 0922945, 0922946, 0922947, 0922952, 0922953, 0922955, 0922956, 0922958, 0922959, 0922960, 0922962, 0922967, 0922968, 0922969, 0922970, 0922971, 0922972, 0945100, 0945101, 0945102, 0945104, 0945105, 0945106, 0945107… Full codes in the FDA record	33,103 devices
Z-0026-2022	OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.; Item Number (Device Identifier; Serial number(s)): 02-012-38-1009 (10885862002358; 2109242, 2109243, 2109244, 2109245, 2109246, 2109247, 2109248, 2109249, 2109250, 2109251, 2109252, 2109253, 2109254, 2109255, 2109256, 2109257, 2109258, 2109261, 2109262, 2109263, 2109265, 2109267, 2109268, 2109269, 2109270, 2109271, 2109272, 2109273, 2109274, 2328032, 2328033, 2328034, 2356324, 2356325, 2356326, 2356327, 2356328, 2356329, 2356330, 2356331, 2356332, 2356334, 2356335, 2356336, 2573198, 2573199, 2573200, 2573201, 2573202, 2573203, 2573204, 2974115, 2974116, 2974117, 2974118, 2974119, 2991806, 2991807, 2991808, 2991809, 2991810, 3628492, 3628493, 3628494, 3628496, 3628499, 3628500, 3628501, 3628502, 3628503, 3628504, 3628506, 3628508, 3628509, 3628510, 3628511, 3826220, 3826221, 3826222, 3870061, 3870062, 3870063, 3870064, 3870065, 3870066, 3870067, 3870068, 3870069, 3870070, 3873437, 3873438, 3873439, 3873440, 3873441, 3873442, 3873444, 3873445, 3873446, 3873447, 3873448, 3873449, 3873451, 3873452, 3873453, 4036097, 4036098, 4036099, 4036100, 4036101, 4036102, 4036103, 4036104, 4036105, 4036108, 4036110, 4036111, 4095990, 4095991, 4095992, 4095993, 4095994, 4095995, 4095997, 4095998, 4095999, 4096000, 4096002, 4096003, 4096004, 4291075, 4291076, 4291077, 4291078, 4291079, 4291081, 4291082, 4291083, 4291085, 4291086, 4291087, 4291088, 4291090, 4291091, 4291092, 4291094, 4291095, 4291096, 4291097, 4291098, 4291099, 4291100, 4291101, 4291102, 4291103, 4706381, 4706382, 4706383, 4706384, 4706385, 4706386, 4706387, 4706389, 4706390, 4766526, 4766527, 4766528, 4766529, 4766530, 4766531, 4766532, 4766533, 4766534, 4901264, 4901265, 4901268, 4901269, 5080411, 5080412, 5080413, 5080415, 5080416, 5080417, 5080418, 5080419, 5080420, 5977948, 5977950, 6112212, 6112218, 6112224, 6112225, 6112226, 6112227, 6112228, 6112229, 6112231, 6561879, 6561886, 6561890, 6561891, 6561892, 6561894, 6561896); 02-012-38-1011 (10885862002365; 2113460, 2113461, 2113462, 2113465, 2113466, 2113467, 2113468, 2113469, 2113470, 2113471, 2113472, 2113473, 2113474, 2113475, 2113476, 2113477, 2113478, 2113479, 2113480, 2113481, 2113483, 2113484, 2113485, 2113487, 2113488, 2256816, 2256817, 2256818, 2256819, 2256820, 2256821, 2378226, 2378227, 2378228, 2378229, 2378230, 2378231, 2378233, 2378234, 2573205, 2573206, 2573207, 2573208, 2573209, 2573210, 2573211, 2573212, 2778423, 2778424, 2778425, 2778426, 2778428, 2939331, 2939332, 2939333, 2939335, 2939337, 2939338, 2939339, 3565084, 3565085, 3565086, 3565087, 3565089, 3565091, 3565092, 3565093, 3565094, 3565095, 3565096, 3565097, 3565098, 3565099, 3565101, 3565102, 3565103, 3870053, 3870054, 3870055, 3870056, 3870058, 3870059, 3870060, 3891149, 3966070, 3966071, 3966073, 3966074, 3966075, 3966076, 3990899, 3990900, 3990901, 3990904, 3990905, 3990907, 4143249, 4143250, 4143251, 4143252, 4143253, 4143255, 4143256, 4143257, 4143258, 4143259, 4143260, 4143262, 4143263, 4143265, 4143266, 4143268, 4143269, 4143270, 4143271, 4143272, 4143273, 4143274, 4143275, 4143276, 4143277, 4476031, 4476032, 4476033, 4476034, 4476035, 4476036, 4476037, 4476038, 4476039, 4476040, 4476041, 4476043, 4476044, 4476045, 4476046, 4476047, 4476048, 4476050, 4476051, 4476052, 4476053, 4476054, 4476057, 4476060, 5236236, 5236238, 5882865, 5882867, 5882869, 5882871, 5882872); 02-012-38-1013 (10885862002372; 2112936, 2112937, 2112939, 2112942, 2112943, 2112945, 2112947, 2112948, 2112949, 2112950, 2112951, 2112952, 2112954, 2112956, 2112957, 2112959, 2112960, 2112962, 2112964, 2112966, 2362197, 2362198, 2362200, 2362205, 2362207, 2573351, 2573353, 2917120, 2917121, 2917124, 2917125, 2917126, 2917127, 2917128, 2917130, 2917131, 3615834, 3615835, 3615841, 3615842, 3826036, 3826037, 3826039, 3826041, 3826043, 3989617, 3989618, 3989619, 3989624, 4152499, 4152504, 4152505, 4152506, 4152510, 4152512, 4152514, 4152521, 5981031, 6411707); 02-012-38-1015 (10885862002389; 2112584, 2112588, 2112594, 2112596, 2112598, 2112600, 2112602, 2573354, 2573355, 2778422, 2901287, 2901289, 2901290, 2901293, 2901294, 3870048, 3870049, 3870051, 3870052, 3991107, 4120497, 4217789, 4217795, 4217813); 02-012-38-1509 (10885862178794; 3616081, 3616082, 3616083, 3616084, 3795243, 3795244, 3795245, 3795247, 3795248, 3836262, 3873433, 4310727, 4310729, 4310730, 4310731, 4310733, 4310734); 02-012-38-1511 (10885862178800; 3607850, 3662935, 3662937, 4259564, 4259566, 4259568, 4259570, 4259572); 02-012-38-1513 (10885862178817; 3873426, 4259573); 02-012-38-2009 (10885862002396; 2113395, 2113396, 2113397, 2113398, 2113399, 2113401, 2113402, 2113403, 2113404, 2113405, 2113406, 2113407, 2113408, 2113409, 2113410, 2113411, 2113412, 2113413, 2113414, 2113415, 2113416, 2113417, 2113418, 2113419, 2113420, 2113421, 2113422, 2113423, 2180482, 2180483, 2180484, 2180485, 2180486, 2180487, 2180488, 2180489, 2180490, 2180491, 2211710, 2211711, 2211712, 2211713, 2211714, 2211715, 2211716, 2211717, 2211718, 2275541, 2275542, 2275543, 2275544, 2275545, 2275546, 2288266, 2288267, 2288268, 2288269, 2288270, 2288271, 2288272, 2288273, 2288274, 2288275, 2288276, 2288277, 2288278, 2288279, 2335401, 2335402, 2335403, 2335404, 2335405, 2335406, 2335407, 2335408, 2335409, 2335410, 2335411, 2335412, 2335413, 2335414, 2382022, 2382023, 2382024, 2382025, 2382026, 2382027, 2382028, 2439391, 2439392, 2439393, 2439394, 2439395, 2439396, 2439397, 2439398, 2439399, 2439400, 2439401, 2439402, 2439403, 2439404, 2439405, 2439406, 2439407, 2439408, 2439409, 2439410, 2523666, 2523667, 2523668, 2523669, 2523670, 2523671, 2523672, 2523673, 2523674, 2523675, 2609827, 2609828, 2609829, 2609830, 2609831, 2609832, 2609833, 2609834, 2609835, 2609836, 2609837, 2609838, 2609839, 2609840, 2609841, 2609842, 2609843, 2609844, 2609845, 2609846, 2609847, 2609848, 2609849, 2609850, 2609851, 2609852, 2609853, 2609854, 2609855, 2609856, 2609857, 2609858, 2609859, 2609860, 2609861, 2707742, 2707743, 2707744, 2707745, 2707746, 2707747, 2707748, 2707749, 2751159, 2751160, 2751161, 2751162, 2751163, 2751164, 2751165, 2751166, 2751167, 2751168, 2751169, 2751170, 2751171, 2751172, 2751173, 2751174, 2789964, 2789965, 2789966, 2789967, 2789968, 2789969, 2789970, 2789971, 2789972, 2789973, 2789974, 2789975, 2789976, 2789977, 2789978, 2789979, 2789980, 2789981, 2848197, 2848198, 2848199, 2848200, 2848201, 2848202, 2848203, 2848204, 2848205, 2848206, 2848207, 2848208, 2901295, 2901296, 2901297, 2901298, 2901299, 2901300, 2901301, 2901302, 2901303, 2901304, 2901305, 2901306, 2901307, 2901308, 2901309, 2901310, 2901311, 2901312, 2901313, 2901314, 2901315, 2901316, 2901317, 2901318, 2901319, 2901320, 2901321, 2901322, 2901323, 2970582, 2970583, 2970584, 2970585, 2970586, 2982066, 2982067, 2982118, 2982119, 2982120, 2982121, 2982122, 2982123, 2982124, 2982125, 2982126, 2982127, 2982128, 2982129, 2982130, 2982131, 3565011, 3565012, 3565013, 3565014, 3565015, 3565016, 3565017, 3565018, 3565019, 3628902, 3628903, 3628904, 3628905, 3628906, 3628908, 3628909, 3628910, 3628911, 3628912, 3628913, 3628914, 3628915, 3628916, 3628917, 3628918, 3628919, 3628920, 3628921, 3628922, 3628923, 3628924, 3628925, 3628926, 3628927, 3628928, 3628929, 3628930, 3628931, 3628932, 3628933, 3628934, 3628935, 3628936, 3628938, 3628939, 3628940, 3628941, 3628942, 3628943, 3628944, 3628945, 3628946, 3628947, 3628948, 3628949, 3628950, 3628951, 3628952, 3628953, 3628954, 3628955, 3628957, 3628958, 3628959, 3628960, 3628961, 3811419, 3811420, 3811421, 3811422, 3811423, 3811424, 3811425, 3811426, 3811427, 3811428, 3811429, 3811430, 3811431, 3811432, 3811433, 3811434, 3811435, 3811436, 3811437, 3811438, 3868596, 3868597, 3868598, 3868599, 3868600, 3868601, 3868602, 3868603, 3868604, 3868605, 3875887, 3875889, 3875890, 3875891, 3875892, 3875893, 3875894, 3875896, 3875897, 3875898, 3875899, 3875900, 3875901, 3875902, 3875903, 3875904, 3875905, 3875906, 3875907, 3875909, 3875910, 3875911, 3875912, 3875913, 3875914, 3875915, 3875916, 3955088, 3955089, 3955090, 3955091, 3955092, 3955093, 3955094, 3955095, 3955096, 3955097, 3955098, 3955099, 3955100, 3955101, 3955102, 3955103, 3955104, 3955105, 3955106, 3955107, 3955108, 3955109, 3955110, 3955111, 3955112, 3955113, 3955114, 3955115, 3955116, 3955117, 3990909, 3990910, 3990911, 3990912, 3990913, 3990914, 3990915, 3990916, 3990917, 3990918, 3990919, 3990920, 3990921, 3990922, 3990923, 3990924, 3990925, 3990926, 3990927, 3990928, 3990929, 3990930, 3990931, 3990932, 3990933, 3990934, 3990935, 3990936, 3990937, 3990938, 4105210, 4105211, 4105212, 4105213, 4105214, 4105215, 4105216, 4105217, 4105218, 4105219, 4105220, 4105221, 4105222, 4105223, 4105224, 4105225, 4105226, 4105227, 4105228, 4105229, 4105230, 4105231, 4105232, 4105233, 4105234, 4105235, 4105236, 4105237, 4105238, 4105239, 4105240, 4105241, 4105242, 4105243, 4105244, 4105245, 4105246, 4105247, 4105248, 4105249, 4161736, 4161737, 4161738, 4161739, 4161740, 4161741, 4161742, 4161743, 4161744, 4161745, 4161746, 4161747, 4161748, 4161749, 4161750, 4161751, 4161752, 4161753, 4161754, 4161755, 4199408, 4199409, 4199412, 4199413, 4199414, 4199415, 4199416, 4199417, 4205609, 4205610, 4205611, 4205612, 4205613, 4205614, 4205615, 4205616, 4205617, 4205618, 4205619, 4205620, 4205621, 4205622, 4205623, 4205624, 4205625, 4205626, 4205627, 4205628, 4236061, 4236062, 4236063, 4236064, 4236065, 4236066, 4236067, 4236068, 4236069, 4236070, 4236071, 4236072, 4236073, 4236074, 4236075, 4236076, 4236077, 4236078, 4236079, 4236080, 4236081, 4236082, 4236083, 4236084, 4236085, 4236086, 4236087, 4236088, 4236089, 4335438, 4335439, 4335440, 4335441, 4335442, 4335443, 4335444, 4335445, 4335446, 4335447, 4335448, 4335449, 4335450, 4335451, 4335452, 4335453, 4335454, 4335455, 4335456, 4335457, 4335458, 4335459, 4335460, 4335461, 4335462, 4335463, 4335464, 4335465, 4335466, 4335467, 4399040, 4399041, 4399042, 4399043, 4399044, 4399045, 4399046, 4399047, 4399048, 4399049, 4399050, 4399051, 4399052, 4399053, 4399054, 4399055, 4399056, 4399057, 4399058, 4399059, 4399060, 4399061, 4399062, 4399063, 4399064, 4399065, 4399066, 4399067, 4399068, 4399069, 4441434, 4441435, 4441437, 4441438, 4441439, 4441440, 4441441, 4441442, 4441443, 4441444, 4441445, 4441446, 4441447, 4441448, 4441449, 4441450, 4441451, 4441452, 4441453, 4441454, 4441455, 4441456, 4441457, 4441460, 4441462, 4441463, 4441464, 4441465, 4441466, 4441467, 4441468, 4441469, 4441470, 4441471, 4441472, 4441473, 4441474, 4441475, 4441476, 4441477, 4441478, 4441479, 4441480, 4441481, 4441482, 4441483, 4441484, 4441485, 4441486, 4441487, 4441488, 4441489, 4441490, 4441491, 4466315, 4466316, 4466317, 4466318, 4466319, 4466320, 4466321, 4466322, 4466323, 4466324, 4466325, 4466326, 4466327, 4466328, 4466329, 4466330, 4466331, 4466332, 4466333, 4466334, 4466335, 4466336, 4466337, 4466338, 4466339, 4466340, 4466341, 4466342, 4466343, 4473859, 4473860, 4473861, 4473863, 4473864, 4473865, 4473866, 4473867, 4473868, 4473869, 4473870, 4473871, 4473872, 4473873, 4473874, 4473875, 4473876, 4473877, 4473878, 4473879, 4473880, 4473881, 4473882, 4473883, 4473884, 4473885, 4473886, 4473887, 4710821, 4710822, 4710823, 4710824, 4710825, 4710826, 4710827, 4710828, 4710829, 4710830, 4710831, 4710832, 4710833, 4710834, 4710835, 4710836, 4710837, 4710838, 4710839, 4710840, 4710841, 4710842, 4710843, 4710844, 4710845, 4710846, 4710847, 4710848, 4723147, 4723148, 4723149, 4723150, 4723151, 4723152, 4723153, 4723154, 4723155, 4723156, 4723157, 4723158, 4723159, 4723160, 4723161, 4723162, 4723163, 4723164, 4723165, 4723166, 4723167, 4723168, 4723169, 4723170, 4723171, 4723172, 4723173, 4723174, 4723175, 4723176, 4810506, 4810507, 4810508, 4810509, 4810510, 4810511, 4810512, 4810513, 4810514, 4810515, 4810516, 4810517, 4810518, 4810519, 4810520, 4810521, 4810522, 4810523, 4810524, 4810525, 4810526, 4810527, 4810528, 4810529, 4810530… Full codes in the FDA record	8,985 devices
Z-0027-2022	ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.; Item Number (Device Identifier; Serial number(s)): 256-12-02 (No Device Identifier; 1208624, 1208625, 1208626, 1208627); 256-12-03 (10885862066633; 1208774, 1446326); 256-13-02 (No Device Identifier; 1208710, 1208715); 256-13-03 (No Device Identifier; 1208859, 1208863); 256-13-04 (No Device Identifier; 1209010, 1209013)	12 devices

Based on the official FDA remedy

What to do — step by step

1
Ensure the device is approved by the FDA or relevant regulatory body.
2
Follow the manufacturer's instructions for use and maintenance.
3
Attend regular follow-up appointments with your healthcare provider.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, ECUADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GHANA, GREAT BRITAIN,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 44 days after the firm started it.

Aug 30, 2021Firm started the recall
Oct 4, 2021FDA classified it Class II
Oct 13, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How often should I follow up after receiving an Exactech implant?

Follow-up appointments typically depend on the type of implant and your individual health status. Your surgeon will provide specific guidance.

Similar recalls

Latest medical device recalls

Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/61862-exactech-medical-devices">Exactech - Medical Devices (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0021-2022 (August 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0021-2022 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.