Z-0549-2025 Class II Ongoing
FDA device recall Z-0549-2025 was initiated by INCIPIO DEVICES on October 30, 2024 and is designated Class II. Reason for recall: Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld. The recall status is ongoing. Affected quantity: 100 units.
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.