FDA · Medical device recall

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell… and 15 more products

Recall started April 16, 2020 · FDA enforcement report May 27, 2020 Class II

Reason: 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.
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…

Enforcement report date: May 27, 2020
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated (FDA's definition: FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard; as in openFDA's data of Nov. 10, 2026)
Filed by: Howmedica Osteonics Corp.
Reason: 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.
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

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“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.”Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17), FDA enforcement report, 2020-05-27. The caption is the record's own words.

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FDA device name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Distributed in (FDA's record): 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

16 products in this recall

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2084-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2085-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2086-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2087-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2088-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2089-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2090-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2091-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2092-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2093-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
Quantity: N/A
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2094-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2095-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2096-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2097-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2098-2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell…

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, Catalog # 504-02-68F-R, UDI (01)07613327012514(17)
Quantity: 4895
Codes and lots: 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
Recall started: April 16, 2020
Recall terminated (FDA): Nov. 15, 2021
Voluntary or mandated: Voluntary: Firm initiated
Device type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Root cause (FDA): Packaging
What the company told customers: Stryker Orthopaedics sent an Urgent Medical Device Recall Letter to consignees on April 16, 2020, to alert them of the packaging failure for the Restoration Anatomic Shell (RAS) implant, sizes 54mm 68mm, (Left and Right). The firm explained that the implant can become loose within the packaging which can result in packaging and/or coating debris. Stryker Orthopaedics instructed the consignees to immediately check all stock areas and/or operating room storage for affected product and inform all users of the recall notice. The notice states that use of affected products should be discontinued. The affected products should be quarantined and returned to Stryker through their Sales Representative or Distributor. The firm requested that consignees return the Urgent Medical Device Recall Business Reply Form within 5 days via fax or email, regardless of whether they have any physical inventory onsite anymore.
Recall number: Z-2099-2020

This recall among the others

FDA's enforcement report came 41 days after the firm started the recall. For half of the 1,088 FDA medical device recall events reported in 2020 with a start date, it took 54 days or fewer (by year).
Howmedica Osteonics: 17 other recalls or notices on this site in the three years before this one (from May 28, 2017).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement reports, recall numbers Z-2084-2020, Z-2085-2020, Z-2086-2020, Z-2087-2020, Z-2088-2020, Z-2089-2020, Z-2090-2020, Z-2091-2020 and others. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record

FDA recall record Z-2084-2020, May 27, 2020. "Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell… and 15 more products." PlainRecords, https://plainrecords.com/recall/device/z-2084-2020/ (as of the day it was built).

At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections

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