FDAFDA · Food and drugs·Recall number Z-0549-2025
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Published December 4, 2024 · Recall initiated: October 30, 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
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- INCIPIO DEVICES
- Distributor
- US Nationwide distribution in the state of TN.
- Lot
- Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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