Lower risk Medical device recall · FDA · Published April 16, 2020

Howmedica Stryker Restoration Anatomic Shell Recall: Packaging May Cause Device to Fall

Howmedica recalls Stryker Restoration Anatomic Hemispherical Shell Size 54 Right. The device may fall off its post in packaging, causing debris to loosen. Consumers should check product details and contact Howmedica for guidance.

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

🇺🇸 FDA recall #Z-2085-2020Medical device Howmedica ›

Lower-risk recall

The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.

Take action

Contact the company

Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006

✎ GovInfoNow plain-language explainer

Howmedica is recalling Stry: 54 Right Stryker Restoration Anatomic Hemispherical Shells due to a risk of the device falling off its post in packaging, which could lead to loose coating debris. This issue affects sterile surgical implants sold with specific catalog numbers and lot numbers. Read more at govinfonow.com/recall/65381-howmedica-stryker-restoration-anatomic-shell-recall-packaging-may-cause-device.

Source Summary by GovInfoNow · govinfonow.com/recall/65381-howmedica-stryker-restoration-anatomic-shell-recall-packaging-may-cause-device · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2085-2020

Cite this page

“Howmedica Stryker Restoration Anatomic Shell Recall: Packaging May Cause Device to Fall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65381-howmedica-stryker-restoration-anatomic-shell-recall-packaging-may-cause-device. Based on FDA recall #Z-2085-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2085-2020%22&limit=1).

Howmedica Osteonics Corp. recalled the Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, due to a hazard where the device may fall off its post, resulting in loose coating debris within the package, according to the FDA. The Food and Drug Administration announced the Class II recall on April 16, 2020.

How to tell if you have it

Brand: Howmedica
Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile
Catalog #: 504-02-54C-R
UDI: (01)07613327012415(17)
UPC: 07613327012415
Lot codes: 6A7N7Y, J50WR6, EM4ED2, 4908KM, K14HL3, VN5NTY, 4X7XE4, JK4A37, W20A86, EM5Y28, H81JNL, EE883L, 9L8LMD, 7Y2HM0, MM0JYY, K23J10, DY42DE, 3P3P64, H77Y5E, MX801E, 1L0758, HM5WKX, D058L6, 4L2R4R, VY0PK4, 872EHV, YD53A4, 4T54D0, 4768E2 WJ0W8W, YV5804, P98YT4, 8N512J, A162RN, J35YL4, H089KL, WW76RP, P58D3J, XH7HN8, RV6DJ8, 8Y0XVE, JM34X2, WJ776A, RH1MRT, N28J76, NP2XXL, L7453E, AA1DYJ, 258Y6J, 6N4X1M, E66DMR, V63W1E, 2739DR, YH1P91, 216NDE, A4410X
Units affected: 4895

The hazard

The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging. This can result in the device being loose in the package with coating debris.

Context

GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Other recent recalls of similar products include Howmedica SCORPIO C-DOME/PATELLA Implants Recall (July 30, 2026), Howmedica Triathlon Baseplate Size 4 Recall (May 19, 2026), and Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (Feb. 2, 2026). Other recent recalls of similar products include Medtronic Bio-Medicus Adult Cannula Kit Recall (May 25, 2026), Stryker BARD EP XT Decapolar Steerable Catheter Recall (April 10, 2026), and Stryker Medtronic Marinr Steerable Catheter Recall (April 10, 2026).

How to tell if you have this one

Check for the product name 'Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell', size 54 Right, sterile, catalog number 504-02-54C-R, and specific lot numbers listed in the recall notice.

Brand
Howmedica
Product
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI
Category
Medical device

FDA recall event · 16 products

All 16 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
Terminated
Distribution
Worldwide distribution including the following states: New York, Arkansas, Oklahoma, Michigan, Delaware, Texas, Louisiana, California, Florida, Arizona, Nevada, Ohio, Colorado, Rhode Island, Iowa, Pennsylvania, Massachusetts, North Carolina, Alabama, New Hampshire, Illinois, New Jersey, Virginia, Utah, Maryland, Mississippi, Missouri, Tennessee, Connecticut, and Kansas

Recall number	Product, codes & lots	Quantity
Z-2084-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17); Lot #s JD8WN9, 6514K5, AD78D5, TR0M4X, YT7R3V, 2A7V17, Y81WDV, AN2DME, 514WVN, 9P3WE4, LD3LAL, L21A8P, K02EYK, 6K0J1W, XK44M4, H55J1M, T10T38, VT07WW, 7T1WTE, 6544JE, J45R2R, 8963DT, LV2EW7, PN1X3T, DN0276, RP35M3, T245XV, 497H8P, LJ52DA, HP48J3, H98XN3, 9E8M7P, 1J1RDH, R235KJ, 793724, RA44MH, JJ65MR, N12K3P, PX3TTK, 425H7M, 3V6JAM, P52HME, WX80AA, K65W39, 1R40DL	4895
Z-2085-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17); Lot #s 6A7N7Y, J50WR6, EM4ED2, 4908KM, K14HL3, VN5NTY, 4X7XE4, JK4A37, W20A86, EM5Y28, H81JNL, EE883L, 9L8LMD, 7Y2HM0, MM0JYY, K23J10, DY42DE, 3P3P64, H77Y5E, MX801E, 1L0758, HM5WKX, D058L6, 4L2R4R, VY0PK4, 872EHV, YD53A4, 4T54D0, 4768E2 WJ0W8W, YV5804, P98YT4, 8N512J, A162RN, J35YL4, H089KL, WW76RP, P58D3J, XH7HN8, RV6DJ8, 8Y0XVE, JM34X2, WJ776A, RH1MRT, N28J76, NP2XXL, L7453E, AA1DYJ, 258Y6J, 6N4X1M, E66DMR, V63W1E, 2739DR, YH1P91, 216NDE, A4410X	4895
Z-2086-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17); Lot #s 4J3N24, W03J5W, N119A4, WK7K99, NM70TR, 3376L4, RK3XRL, RH27YA, M00KML, TM2MMK, PW30H8, DL01A0, WD4T0V, 2D40YA, 4Y5LAE, W63A8E, VJ34EV, AR5H0T, HY6Y45, KV2835, P84X94, KK0AVP, 2M8RW6, AL0AR3, TP1Y1H, W66X1L, PH28V2, P00606, 3Y3MHV, V32P52, EJ32W6, HN8HXP, 2V46PY, TD1A6J, 7R1X76, W62DKJ, N3435R, W92EP4, HJ0X8X, 5E3X1N, P53NP4, DJ2WKH, P32YRY, X62L47, XV86AL, XV2EY5, 108Y9R, T143LR, VH573D, W56T4K, A071R3, V319PM	4895
Z-2087-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17); Lot #s AX3V4E, DX109D, TD2X0H, JV415X, KW5467, HM4L3L, WK5WV2, LD2HHY, A67ERK, Y579RW, RW1XVW, VJ7TE0, M02DYJ, EW1TJ5, 371T2M, 2W3T75, 345TJ9, N968R7, H386RY, 978TAX, L6266H, JV4M06, Y7169E, M840TN, 9D6PY0, TV06A0, PR2X50, P85T79, 4M5N2M, 9P3RN6, 247VR6, WE2A2A, 65792M, HA59H2, 4N6HT3, 7N01JA, 762PPX, 2D8P93, 2V4609, NE509M, VJ4RT3, KM720L, 7J3TRH, DP1EDA, V2760N, X05E74, D477X9, R372K2, TR0YTY, P720M0, Y63AD0	4895
Z-2088-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17); Lot #s EE5WWV, DY6V66, 4T75EE, HT3X47, YX8KLL, 99554T, T58TR0, A46AJA, P23W2H, 9X0WHV, 681E6V, XP0AKD, RD53PW, R67PR4, N11PLW, WW20KE, KV6P9X, 6X4R9T, 2X4KLD, M08065, VN205Y, Y68MTM, EP6P1E, E257HE, PP894J, 4X47VL, 7J0H1A, K50T9R, 2E2139, V92X6Y, T42NM1, LV7LYM, RV8RWH, 2E5WH7, 8H3HK1, JV2PT1, PT243R, M30439, RH817R, XT5R2K, 112LE7, 4J485X, D360KK, PM5R68, KN48NR, LT1YKM, H82NXR, VP8MRR, 4Y44YM, V27D3P, N40RWX, YE2L2E, H500TT	4895
Z-2089-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17); Lot #s 5L0YLY, DN3EJH, Y62465, 288DP4, LW0D2K, 3K4R62, KN2W5X, M44PVH, 3W01XK, 1Y123H, M55NTP, 683N70, JN4PR7, 497YJX, L022L2, 37889P, X86194, 775A9V, X30XTJ, W333HY, H376E6, 1V4A3X, TP5KK8, VA13MW, 9W0HD6, V72LA3, 3V1WAR, 4H7V1M, 173VRV, 9A4D9X, JE6E3M, 9H2LYX, T532A9, WJ72K7, HX5AN0, XM1A2X, 9T3XPK, TR8WMV, 9A8X5J, 5D78YR, RK0MJJ, PL0LA1, 6P4VX9, A83DPD, 8X715Y, WM2AHV, 1M5P7E, 2E36LW, X81L96	4895
Z-2090-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17); Lot #s Y461NK, 916M1K, 3581JK, 306XWX, AH4AER, YP48JA, 6J7PTL, KT81WD, 1D6NNE, 467JP5, 6M025E, T4286L, 633D81, 6L6ADX, N175H8, WJ41VD, RM697T, A602M0, 840Y1A, 988KM2, LL2VPW, Y37LK3, M35P5P, 280YM6, R62EM9, WM4W56, JE46JM, AK0560, D11734, EK644L, D802YL, HP25TN, L618D8, N532D2, NW0M02, 972H4A, 95171N, JD4934, WN7K01, V8245A, AK00NH, VL1688, 2E7J6X, 5030EN, P13E4K, K94NEN, MA5W63, 8X783D, 5A3RW3, TV13J7	4895
Z-2091-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17); Lot #s 9Y6675, 2J7WNV, A02X70, ME3841, P94D02, TD37HJ, DT8E38, LM49H5, WE24MT, 74064X, A36853, 694L07, YJ3J46, H26D71, 9X2RDX, AV6M23, L686MM, JY3288, MV2HXY, NP416P, 2L349V, XT6WTY, H02LL7, 601W6E, 6X855W, PV8H2X, R846J8, L705V1, D62TJ0, TM88WY, JE7AW0, 6W0DE9, 3400PT, D62345, 2E6E25, 422V52, 5R8KH0, VE2X77, W56APY, 8267AV, YH5N6L, P32YNV, T5091D, 4M46YJ, 7N4HW9, MM0T9T, XL0WKM	4895
Z-2092-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17); Lot #s EK2JXE, V26EXD, K97J79, MV20HR, RM5RX2, 478E97, ET7EXW, J74RKR, L71A2P, P276D0, M15D1R, ND74JJ, 6P6MWY, X500MV, K931PP, 6J36RW, MH415K, T96X19, VM332V, WW65Y5, X13MJV, L97NMP, RL4L86, MR1RLA, MN1P4X, R91A0P, N76VMX, W361J6, RL4L13, Y36651, PA8JD4, NA049P, 8V5K0A, 5M8HYP, 896EHD, 232R3X, 5D2PDD, T137D5, ML43R3, 5R6RN3, DT11P7, N07WMV, VR591J, 7H32J5, 903NRE, 1X5HLV, AA5Y4M, WL5KR3, PR4Y4L, JL7L46, 9K37HW, NA0N94, YA7HX9, AX89T7, RH44YE, 8E30L6, N411HJ, 3V37MK	4895
Z-2093-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17); Lot #s PH230T, 5316PX, 6487DY, MV4KAW, MY6XW7, NY7JW8, XT3NK1, 8J1031, W43YMN, Y363WD, R58ALD, YM0ATP, MD6J43, M04YA2, 1V4RY5, NY85E3, 9439YT, KR3025, NN41PD, W28H8N, 7T0V3R, MT7MA3, PW531T, JT1H7A, WL30XL, LN8LTY, HJ82TV, XN0HR9, RY7TH7, L97718, KN4A66, JE84VV, 5X3H7R, 404547, 86593Y, 7610XX, WY3E23, JH7RH6, HD1H4E, 59725R, T17YD9, KX6P0W, 4A4TW6, 42775A, E02TD6, 3M44J8, DM2L4J, YX2RMM, 9L6EN0, NJ69D3, 4P7MTN, 2P31RY, 935J0K	4895
Z-2094-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17); Lot #s Y32LP9, AN6ATN, A77J57, EE69A8, 625VEM, K8549T, EV6MXD, L85MMA, 7E2R48, M21Y21, H71N5N, A74YXL, PN2X3H, V2774X, AE6LJR, 7D0YJE, 6957YA, LM5N9M, 477ELH, JN8347, AY8T8N, EM0W77, TL29PE, NX79TH, 956DXP, A86VNH, KX5MX1, WW7VPM, 7A58DL, 37348T, N80109, 1269DY, 2351A5, H58V9W, 5M1K6H, T3509E, HL627T, WY1XP7, A76DE6, PX677J, AK4L6N, EA2MNR, AM5H8X, KM0M7W, D33PLA, 7R165A	N/A
Z-2095-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17); Lot #s J4895V, V9556J, RA3188, DH4RW8, WH083M, KY10DV, 937YAE, XJ1WW1, K52EHL, JX5291, M50LV5, 561RR3, 847AX0, V3377L, EJ40D2, W40V6T, TD3H2L, 9X0DHT, LL7R18, 9N0LH6, 6874DA, Y114EE, PP6X0D, NH50PJ, 6P32NN, MA1VYD, 328L1T, 52028A, X800K7, L51VJR, M22WTW, W80LRW, NV83VN, Y54MNA, V74712, EH1VK4, D9414T, PA6RRP, NT8241, 3P112L, NW7K52	4895
Z-2096-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17); Lot #s HP3142, J93277, HK4HK0, N18T96, 590V0J, WA1D8T, 6D4MT7, 2V3A9W, HE19E5, JN2DWN, 777N5V, YY4LXE, JA0986, 213804, 86112L, 8X4H1D, N25J45, EM8Y25, 647TEX, J011V3, N75WT3, H98AT2, JD1K8M, M576M5, 8Y64X7, E810LX, 7J2099, RH6TNE, HR6M1R, 101MM7, V76WAA, TX6X20, 8N36E0, 3T6330, MR025M, WL6T19, 9K2L3R, K53TKW, RT8P7Y, M82N19, 7E1R1Y, TJ56KK, RX8HHY, NJ4XWJ, WM5VVN	4895
Z-2097-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17); Lot #s 1X5DJK, NH4W8Y, 744EH9, AD25RA, 7E4HW3, 1N21NK, E00T60, WY1DD1, D26R36, H74H7L, RT0AK2, 593Y5R, AD00T8, E12H25, 9K66L6, AL7K8E, MP11MY, D04T4A, 8K74RX, 1R57DY, NH0352, KW5K62, 767RKK, V21PPJ, 6580X6, X73EDY, 5A1ANY, LJ0DWY, RR0T4W, JA761W, N11LR0, 1A03DE, 5E7XRM, TW81AP, 7E69MM, M42Y3R, A28827, 5N1DTH, Y6782W, J33J50, D930PJ, XR6WL0, TH4ED5, J54YNJ, D755P9	4895
Z-2098-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17); Lot #s YX05L9, AL6MM6, VX02E2, 5Y1H86, XY5HP7, MA49HV, A26E76, 4V4APT, LD87TH, MH1RLL, 8R05HH, A67K6H, Y00YXH, PA02HR, LE0L4W, 494M8R, 4T4RAV, PW2E41, 3T59A5, T384A0, PD2Y0T, V44JY5, 650WXN, 3D3H6W, DT2YN6, M550AN, 3N0PN7, YA60V9, DV13RY, 4M1NHR, 3M48X6, LR49YE, NT897W, DX8JV1, VN44ME, VR1H7D, TW4EJ0, T722PN, 6V04AX, 390D9L, KW3W1W, 4D6DWK, W079A2, Y81W0J	4895
Z-2099-2020	Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, Catalog # 504-02-68F-R, UDI (01)07613327012514(17); Lot #s DD6E5N, 3314LE, EA67YJ, TA05PD, MJ71XA, VH242D, HR43JY, 5E8XPW, KR4YH2, XW7T57, W92MH8, DY1N6E, 4D8EEY, 6M7D2N, 1T81T1, V45AA1, YL2DP4, H017J0, 850EJX, DA1ATY, E78XK4, KN8JXW, VH5DWP, JX71XR, 148L96, KR69DY, M109P1, MK3VNM, X50AR7, KW011V, XM59HJ, 8Y47TR, JD72RX, ND5JDA, T92XV4, 5K7V66, YN3J9D, 8J4YER, A74527, KE1HDR, H5565X, 4L4K4N, PT47V2, 6J83LP, RX1MM4, 5L6P60, L90X5H, 7X117R, MA78Y5	4895

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product by checking the catalog number (504-02-54C-R) and lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in 30 states, and outside the U.S.

FDA distribution: “Worldwide distribution including the following states: New York, Arkansas, Oklahoma, Michigan, Delaware, Texas, Louisiana, California, Florida, Arizona, Nevada, Ohio, Colorado, Rhode Island, Iowa, Pennsylvania, Massachusetts, North…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Illinois, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

Apr 16, 2020Firm started the recall
May 21, 2020FDA classified it Class II
May 27, 2020Published in FDA’s Enforcement Report
Nov 15, 2021FDA terminated the recall

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

Is this product safe to use?

The recall indicates a potential risk of the device falling off in packaging, but the product is safe for use once properly installed in the surgical procedure.

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Link to this recall

<a href="https://govinfonow.com/recall/65381-howmedica-stryker-restoration-anatomic-shell-recall-packaging-may-cause-device">Howmedica Stryker Restoration Anatomic Shell Recall: Packaging May Cause Device to Fall (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-2085-2020 (April 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2085-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.