FDA Enforcement
Class II
Ongoing
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Recall: Z-0549-2025
·
Reported December 4, 2024
Enforcement
- Recall Number
- Z-0549-2025
- Event ID
- 95653
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- INCIPIO DEVICES
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 4, 2024
- Initiation Date
- October 30, 2024
- Classification Date
- November 25, 2024
- Address
- avenue des Paquiers 16, St-Blaise, N/A, Switzerland
Description
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Reason
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Code Info
Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
Distribution
US Nationwide distribution in the state of TN.
Quantity
100 units