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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Howmedica Osteonics Corp.: 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.

Agency Publication Date: May 7, 2020
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Affected Products

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85583
Status: Resolved
Manufacturer: Howmedica Osteonics Corp.
Manufactured In: United States
Units Affected: 15 products (4895)
Agency Last Updated: May 21, 2020

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.