FDAFDA · Food and drugs·Recall number Z-0326-2025
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.
Published November 13, 2024 · Recall initiated: October 15, 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
The Bipolar assembly contains an oversized Retainer Ring.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
- Lot
- Batch W2401399, UDI-DI 03596010494375.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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