FDA Device recall Z-2091-2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
- FDA Device
- Class II
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class II recall of Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17) by Howmedica Osteonics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2091-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-16 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Howmedica Osteonics |
| Distribution | AL, AR, AZ, CA, CO, CT, DE, FL, IA, IL, KS, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA |
Product
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
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.
Identifiers
| code_info | Lot #s 9Y6675, 2J7WNV, A02X70, ME3841, P94D02, TD37HJ, DT8E38, LM49H5, WE24MT, 74064X, A36853, 694L07, YJ3…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2091-2020%22
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