INCIPIO DEVICES: Device Recall
Recall #Z-0549-2025 · 10/30/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0549-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- INCIPIO DEVICES
- Status
- Ongoing
- Date Initiated
- 10/30/2024
- Location
- St-Blaise, Switzerland
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
Reason for Recall
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Product Description
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Distribution Pattern
US Nationwide distribution in the state of TN.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.