Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell — Class II medical device recall Z-2088-2020
Terminated recall by Howmedica Osteonics Corp., reported 2020-05-27, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result
| Recall number | Z-2088-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2020-04-16 |
| Classified | 2020-05-21 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2021-11-15 |
| Distributed | 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 |
| Quantity | 4,895 |
| UPC / GTIN / UDI-DI | 07613327012347 |
| Lot numbers | 112LE7, 2E2139, 2E5WH7, 2X4KLD, 4J485X, 4T75EE, 4X47VL, 4Y44YM, 681E6V, 6X4R9T, 7J0H1A, 8H3HK1, 99554T, 9X0WHV, A46AJA, D360KK, DY6V66, E257HE, EE5WWV, EP6P1E, H500TT, H82NXR, HT3X47, JV2PT1, K50T9R, KN48NR, KV6P9X, LT1YKM, LV7LYM, M08065, M30439, N11PLW, N40RWX, P23W2H, PM5R68, PP894J, PT243R, R67PR4, RD53PW, RH817R and 13 more |
| Model numbers | 504-02-56D-R |
Product
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2088-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.