Lower risk Medical device recall · FDA · Published April 18, 2024
Exactech OPTETRAK Inset Patella Recall: Out of Specification Vacuum Bags
Exactech recalls specific OPTETRAK Inset Patella knee components due to out of specification vacuum packaging. Affected items have model numbers 200-05-23, 200-05-26, or 200-05-29. Consumers should check their product details.
Lower-risk recall
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Contact the company
Recalling firmExactech, Inc.2320 Nw 66th Ct · Gainesville, FL 32653-1630
What happened, in plain English
Exactech is recalling certain OPTETRAK Inset Patella knee components because they were packaged in vacuum bags that don't meet quality specifications. This could lead to improper fitting or failure during use, but the recall doesn't specify immediate safety risks. Read more at govinfonow.com/recall/55345-exactech-optetrak-inset-patella-recall-out-of-specification-vacuum-bags.
Source Summary by GovInfoNow · govinfonow.com/recall/55345-exactech-optetrak-inset-patella-recall-out-of-specification-vacuum-bags · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2157-2024
Cite this page
“Exactech OPTETRAK Inset Patella Recall: Out of Specification Vacuum Bags.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55345-exactech-optetrak-inset-patella-recall-out-of-specification-vacuum-bags. Based on FDA recall #Z-2157-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2157-2024%22&limit=1).
Why it’s dangerous
The knee components were packaged in vacuum bags that don't meet quality specifications. This could cause improper fitting or failure during use, but the recall doesn't indicate immediate safety risks like injury or malfunction.
Who’s affected
People who own or use Exactech OPTETRAK Inset Patella knee components with model numbers 200-05-23 (23MM), 200-05-26 (26MM), or 200-05-29 (29MM) are affected. Those with these specific model numbers are most at risk.
How to tell if you have this one
Check for model numbers 200-05-23 (23MM), 200-05-26 (26MM), or 200-05-29 (29MM) on the product. The recall includes specific lot numbers associated with these model numbers.
- Brand
Exactech- Category
Medical device
All 4 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.
| Recall number | Product, codes & lots |
|---|---|
| Z-2155-2024 | OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;; a) 200-02-26, UDI/DI 10885862039576, Lot Numbers: 5881807, 5908515, 5968530, 6007309, 6038708, 6038717, 6066779, 6345487, 6345502, 6358520, 6431224, 6431231, 6551547, 6557360, 6723682, 6734364, 6771158, 6865729, 6910696, 6910715, 6910718, 6910745, 6910752, 6910779, 7017876, 5968531, 6161207, 6383171, 6358523, 6601196, 6910805, 6066775, 6424212, 6431232, 7017878, 6406114, 6601148, 6161158, 6161182, 6470948, 6470955, 5968547, 6004184, 6383177, 6514106, 6551513, 6551531, 6551534, 6601150, 6672159, 6723663, 6723679, 6910704, 6007300, 6007323, 6007306, 6383158, 6181021, 6530351, 6530359, 6910787, 6514153, 6557339, 6557341, 6066789, 6457006, 6007299, 6530338, 6601188, 6621896, 6672158, 6865746, 6910794, 6004190, 6601141, 6601180, 6716699, 6716716, 7017894, 6038704, 6038713, 6457023, 6530356, 6668072, 6672152, 6723670, 6723690, 6038746, 6203999, 6371789, 6371797, 6371819, 6424210, 6431226, 6601165, 6601181, 6601195, 6672143, 6672148, 6734373, 6865718, 6865731, 6865736, 6865748, 6865750, 6910758, 6910759, 6910761, 6910778, 6910788, 7017895; b) 200-02-29, UDI/DI 10885862039583, Lot Numbers: 5879069, 6007378, 6007384, 6160756, 6160758, 6516483, 6530381, 6530425, 6631144, 6666877, 6666893, 6716571, 6716613, 6721823, 6741812, 6857688, 6919108, 6083494, 6530382, 6555638, 6979180, 6005908, 6005941, 6160736, 6160755, 6516968, 6559612, 6673204, 6803850, 6881661, 6110574, 6160509, 6982513, 6555598, 6555750, 5901678, 6530553, 6530562, 6709794, 6866198, 6530428, 6530534, 6530571, 6631384, 6725048, 6918774, 6206453, 6516950, 6530404, 6530546, 6559642, 6559778, 6673145, 6784688, 6784711, 6784717, 6005907, 6007171, 5878953, 6160760, 6160765, 6206455, 6530391, 6530422, 6555026, 6555618, 6559733, 6643090, 6666889, 6709806, 6721849, 6736483, 6848341, 6910605, 6918890, 6981879; c) 200-02-32, UDI/DI 10885862039590, Lot Numbers: 5865261, 6066890, 6529343, 6636250, 6646113, 6741660, 6812750, 6832689, 6631118, 6646171, 6897705, 6036281, 6046542, 6774341, 6776375, 6776465, 6161541, 6457699, 6470232, 6529411, 6621368, 6631108, 6636243, 6457685, 6857923, 6866377, 6529386, 6621380, 6646184, 6162074, 6162084, 6532564, 6551720, 6897690, 6092331, 6204036, 5879200, 6621788, 6646177, 6776406, 6812673, 6590081, 6636222, 6671944, 6776390, 6812686, 6882843, 6086424, 6110447, 6499773, 6502538, 6502542, 6607208, 6741649, 6784543, 6898355; d) 200-02-35, UDI/DI 10885862039606, Lot Numbers: 6083434, 6083438, 6331762, 6515586, 6645576, 6756391, 6869962, 6986421, 7035009, 5886784, 6547109, 6631290, 6860839, 6083417, 6162448, 6162466, 6607099, 6630977, 6643152, 6645564, 6724011, 6560456, 6896425, 6896845, 6813363, 6417511, 6981313, 6668734, 6986410, 6187587, 6896453, 6560529, 6784601, 6003738, 6043752, 6560452, 6982298, 6645561, 6038659, 6044116, 6547166, 6709766, 6741638, 6784626, 6897269, 6982290, 6066900, 6066904, 6593133, 6716418, 6813380, 6856198, 6043758, 6043759, 6502461, 6502477, 6528571, 6860793, 6869996, 6897321, 6919031; e) 200-02-38, UDI/DI 10885862039613, Lot Numbers: 5908394, 5956763, 6007401, 6162652, 6162653, 6499738, 6562077, 6562880, 6607038, 6630515, 6710008, 6840536, 6840547, 6850839, 6850845, 6910559, 6910564, 6007417, 6667841, 6529888, 6840542, 6774457, 6981964, 6667868, 6162628, 6162676, 6382287, 6562053, 6562849, 6607011, 6621318, 6305341, 6382295, 6405731, 6499710, 6740028, 6840242, 6188399, 6162629, 6162639, 6607029, 6896385, 6981923, 6003469, 6740033, 6774460, 6981928, 6562023, 6606987, 6866541, 6621336, 6840240, 5956757, 6039164, 6162684, 6204860, 6499730, 6562812, 6850866, 6866540, 6866543, 6882197, 6910516, 6067850, 6067855, 6067858, 6162664, 6436339, 6709992, 6740067, 6840554, 6043133, 6043150, 6086648, 6162656, 6384369, 6384557, 6384577, 6646847, 6751532, 6840265, 6840278, 6882233, 6896358, 6910557, 6981971; f) 200-02-41, UDI/DI 10885862039620, Lot Numbers: 5914786, 5956785, 5956787, 6012382, 6012386, 6038392, 6083318, 6083326, 6083330, 6083337, 6219023, 6458802, 6522923, 6547557, 6547587, 6646426, 6755032, 6755053, 6901014, 6936833, 6936863, 6936880, 6936886, 6623181, 6672079, 6901034, 6936879, 6083333, 6185479, 6561274, 6777289, 6012395, 6219030, 6436362, 6623186, 6801028, 6801025, 6801046, 6012363, 6012364, 6012405, 6853482, 5956792, 6083311, 6083320, 6522950, 6672071, 6219019, 6458795, 6458808, 6522947, 6561273, 6646421, 6646437, 6853491, 6900982, 6936850, 6623169, 6646416, 6901002, 6083327, 6547566, 6522932, 6561261, 6623170, 6547591, 6672097, 6853493, 6458807, 6522931, 6547613, 6561272, 6672082, 6777287, 6083347, 6646431, 6801037, 5956800, 6012361, 6012411, 6012415, 6206361, 6646428, 6801019, 6801034, 6801048, 6853485, 6522926, 6561254, 6721787, 6801023, 6801027, 6801029, 6801031, 6853477, 6853478, 6853480, 6936842, 5956798, 5956958, 6038367, 6038389, 6083335, 6162381, 6185492, 6206350, 6206353, 6206366, 6219022, 6219029, 6458793, 6547583, 6646440, 6672098, 6721794, 6755043, 6801045, 6853476, 6901000, 6901007, 6901016 |
| Z-2156-2024 | OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM; a) 200-03-26, UDI/DI 10885862039637, Lot Numbers: 6389536, 6389549, 6389551, 6389538, 6389540, 6389531, 6389537, 6389529, 6389534, 6389542, 6389545, 6711546, 6711550, 6389547, 6389548, 6389555, 6711540; b) 200-03-29, UDI/DI 10885862039644, Lot Numbers: 6276447, 6276452, 6385318, 6385319, 6607740, 6385323, 6385304, 6385321, 6276446, 6276448, 6385300, 6276442, 6385310, 6385316, 6385325, 6607741, 7037109, 6276425, 6276429, 6276428, 6276433, 6276450, 6276453, 6607760, 6276437, 6276440, 6607751, 6607754, 6276426, 6276445, 6276449, 6607744, 6607759, 6276434, 6276435, 6276443, 6276451, 6385307; c) 200-03-32, UDI/DI 10885862039651, Lot Numbers: 6385285, 6385286, 6844803, 6844831, 6385268, 6385278, 7043349, 7043358, 7043331, 6844822, 6385266, 6385269, 6385272, 6385277, 6385274, 7043330, 7043333, 7043336, 7043337, 7043342, 7043343, 7043356, 6385273, 6385281, 6385294, 6844804, 6844817, 6844818, 6844826; d) 200-03-35, UDI/DI 10885862039668, Lot Numbers: 6711235, 6711254, 7044342, 7044351, 7044345, 6711236, 6711253, 7044338, 7044347, 7044349, 7044348, 6711245, 7044352, 7044336, 7044350; e) 200-03-38, UDI/DI 10885862039675, Lot Numbers: 6401867, 6401876, 6401870, 7043457, 6401882, 6401868, 6401871, 7043466, 7043474, 6401858, 6401872, 7043460, 6923186, 6401873, 6923184, 6401855, 6401860, 6401877, 6401879, 7043459, 7043463; f) 200-03-41, UDI/DI 10885862039682, Lot Numbers: 6389208, 6389211, 6389221, 6389216, 6389215, 6389220, 6389225, 6389213, 6389223, 6389224, 6389217, 6389226, 6389210, 6389222, 6389214, 6389207, 6389212, 6389219 |
| Z-2157-2024 | OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM; a) 200-05-23, UDI/DI 10885862039835, Lot Numbers: b) 200-05-26, UDI/DI 10885862039842, Lot Numbers: c) 200-05-29, UDI/DI 10885862039859, Lot Numbers: |
| Z-2158-2024 | OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM; a) 200-07-26, UDI/DI 10885862314260, Lot Numbers: 5937497, 6015804, 6038627, 6038629, 6038631, 6067823, 6067835, 6067836, 6305296, 6305298, 6305299, 6535789, 6535803, 6535805, 6535809, 6590076, 6645243, 6673338, 6786230, 6786240, 6786241, 6535796, 6535800, 6535816, 6645242, 6786226, 6038630, 6535815, 6645241, 6739854, 6673345, 6535784, 6645237, 6739847, 6786239, 6535791, 6535797, 6535801, 6535814, 6535813, 6535818, 6590073, 6590075, 6535785, 6535793, 6786235, 6786236, 6015801, 6038621, 6038623, 6038634, 6535799, 6590070, 6739858, 6015793, 6067825, 6305288, 6305297, 6535783, 6535819, 6590071, 6739843, 6739855, 6739860, 6786225, 6786228; b) 200-07-29, UDI/DI 10885862314277, Lot Numbers: 6645889, 6772402, 6533499, 6752332, 6772396, 6832365, 6982420, 6323576, 6832362, 6832369, 7011431, 6549464, 6208480, 6645945, 6865835, 6865866, 6316340, 7044556, 6533462, 6856163, 6866305, 7011384, 7011417, 7044569, 7044578, 6777243, 7057281, 6982471, 7011389, 7011418, 7044584, 6772382, 6866307, 7057296, 6406015, 6524753, 6533476, 6606329, 6606332, 6672745, 6730135, 6749434, 6749437, 6749481, 6865871, 7011383; c) 200-07-32, UDI/DI 10885862314284, Lot Numbers: 6643242, 6011209, 6896812, 6504988, 6747994, 6643251, 7057358, 6504922, 6896823, 6012456, 6311777, 6516256, 6516259, 6606125, 6771958, 6965420, 7009622, 7057577, 7057703; d) 200-07-35, UDI/DI 10885862314291, Lot Numbers: 6910903, 6385204, 6524726, 6540451, 6853437, 6853455, 6973342, 7031138, 6385363, 6524696, 6606620, 6672470, 6754472, 6754523, 7031154, 7031155, 6524722, 6621734, 7004924, 6606280, 7044376, 6054711, 6973348, 6536461, 6540445, 6590022, 6738250, 6910891, 6041100, 6524685, 6524708, 6606631, 6621723, 6646277, 6646284, 6752047, 6801191, 6814395, 6853451, 6897017, 7044357; e) 200-07-38, UDI/DI 10885862314307, Lot Numbers: |
What to do — step by step
Check Product Details
Identify the model number and size (23MM, 26MM, or 29MM) to confirm if your item is affected.
How this recall unfolded
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
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-2157-2024 (April 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2157-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.