GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600 — Class II medical device recall Z-0487-2022
Terminated recall by DePuy Orthopaedics, Inc., reported 2022-01-19, distributed nationwide. Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not
| Recall number | Z-0487-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2021-12-07 |
| Classified | 2022-01-11 |
| Reported by FDA | 2022-01-19 |
| Terminated | 2024-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, DK, EE, FI, FR, GB, GR, IE, IL, IT, NL, NO, NZ, PL, SE, TH, ZA |
| Quantity | 3 units |
| UPC / GTIN / UDI-DI | 10603295004097 |
| Lot numbers | 9809673 |
Product
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Reason for recall
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
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-0487-2022. 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.