Reported May 27, 2020 · Terminated
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI…
Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
- Lot codes and dates
Lot #s AX3V4EDX109DTD2X0HJV415XKW5467HM4L3LWK5WV2LD2HHYA67ERKY579RWRW1XVWVJ7TE0M02DYJEW1TJ5371T2M2W3T75345TJ9N968R7H386RY978TAXL6266HJV4M06Y7169EM840TN9D6PY0TV06A0PR2X50P85T794M5N2M9P3RN6247VR6WE2A2A65792MHA59H24N6HT37N01JA762PPX2D8P932V4609NE509MVJ4RT3KM720L7J3TRHDP1EDAV2760NX05E74D477X9R372K2TR0YTYP720M0Y63AD0
- Amount recalled
- 4895
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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