FDAFDA · Food and drugs·Recall number Z-1901-2024
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
Published June 5, 2024 · Recall initiated: April 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Packaging contained the incorrect size of femoral head from what was displayed on the label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew Inc
- Distributor
- International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
- Lot
- REF 71343204 - Batch #23FM03219, Exp. June 2033; REF 71343604 - Batch 23FM04184, Exp. June 2033.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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