Recall archive / FDA device enforcement
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, f... — FDA record Z-0326-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 15, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- The Bipolar assembly contains an oversized Retainer Ring.
- Classification
- Class II
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 21 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0326-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Batch W2401399, UDI-DI 03596010494375. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 13, 2024
- Recall initiation date
- Oct 15, 2024
- Center classification date
- Nov 7, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.