Tandem Intl Bipolar Cocr Shell/UHMWPE Liner — Class II medical device recall Z-0326-2025
Ongoing recall by Smith & Nephew, Inc., reported 2024-11-13. The Bipolar assembly contains an oversized Retainer Ring.
| Recall number | Z-0326-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2024-10-15 |
| Classified | 2024-11-07 |
| Reported by FDA | 2024-11-13 |
| Countries outside the US | AU, BE, CA, DE, ES, IT, PA, PL, TR |
| Quantity | 21 devices |
| UPC / GTIN / UDI-DI | 03596010494375 |
| Lot numbers | W2401399 |
| Model numbers | 71324046 |
Product
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
Reason for recall
The Bipolar assembly contains an oversized Retainer Ring.
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-0326-2025. 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.