Device product
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Z-0549-2025
Product summary
- Firm
- INCIPIO DEVICES
- Event
- Event 95653
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-0549-2025
Official wording
Reason: Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Code information: Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
Distribution pattern: US Nationwide distribution in the state of TN.
Derived failure modes
-
Potency or specification failure
does not meet specification