Z-0549-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- October 30, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
Product Description
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Reason for Recall
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Distribution Pattern
US Nationwide distribution in the state of TN.
Code Information
Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.