ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee… — Class II medical device recall Z-2348-2021
Terminated recall by DePuy Orthopaedics, Inc., reported 2021-09-01. Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
| Recall number | Z-2348-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2021-07-01 |
| Classified | 2021-08-25 |
| Reported by FDA | 2021-09-01 |
| Terminated | 2023-02-01 |
| Countries outside the US | CA, FR |
| Quantity | 7 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10603295043010 |
| Lot numbers | J82N61 |
| Model numbers | 1512-16-080 |
| Expiration dates | 2030-05-31 |
Product
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Reason for recall
Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
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-2348-2021. 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.