Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85583

16 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 16, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Howmedica Osteonics Corp.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

16 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)

Z-2084-2020
Recall number
Z-2084-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 2 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17)

Z-2085-2020
Recall number
Z-2085-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 3 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)

Z-2086-2020
Recall number
Z-2086-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 4 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)

Z-2087-2020
Recall number
Z-2087-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 5 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)

Z-2088-2020
Recall number
Z-2088-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 6 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17)

Z-2089-2020
Recall number
Z-2089-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 7 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)

Z-2090-2020
Recall number
Z-2090-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 8 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)

Z-2091-2020
Recall number
Z-2091-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 9 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17)

Z-2092-2020
Recall number
Z-2092-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 10 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)

Z-2093-2020
Recall number
Z-2093-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 11 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)

Z-2094-2020
Recall number
Z-2094-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 12 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17)

Z-2095-2020
Recall number
Z-2095-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 13 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)

Z-2096-2020
Recall number
Z-2096-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 14 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17)

Z-2097-2020
Recall number
Z-2097-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 15 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17)

Z-2098-2020
Recall number
Z-2098-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

device · product 16 of 16

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, Catalog # 504-02-68F-R, UDI (01)07613327012514(17)

Z-2099-2020
Recall number
Z-2099-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
4895

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for 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.

Code information

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

Distribution pattern

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

Field note

Send feedback

We'll only use this to respond to your feedback.