Reported Dec 4, 2024 · Ongoing
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Incipio Devices
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: INCIPIO DEVICES · avenue des Paquiers 16 · St-Blaise · N/A
Is this the product you have?
- Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
- Lot codes and dates
- Product Reference No.: 50341105
- UDI-DI
07630055304735Lot No.: 24A0087
- Amount recalled
- 100 units
Where it was sold
- Nationwide
- TN
Why it was recalled
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
This product could cause temporary or reversible health problems — stop using it.
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