Recall archive / FDA device enforcement
smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF... — FDA record Z-1901-2024
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 Apr 24, 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
- smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
- Reason
- Packaging contained the incorrect size of femoral head from what was displayed on the label.
- Classification
- Class II
- Recalling firm
- Smith & Nephew Inc
- Quantity
- 23 packages
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1901-2024
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 | REF 71343204 - Batch #23FM03219, Exp. June 2033; REF 71343604 - Batch 23FM04184, Exp. June 2033. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 5, 2024
- Recall initiation date
- Apr 24, 2024
- Center classification date
- May 24, 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.