Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
This recall is currently active, issued November 25, 2024. It was issued by Incipio Devices Avenue Des Paquiers 16 St-Blaise Switzerland.
- Recall Initiated
- October 30, 2024
- Posted
- November 25, 2024
- Recall Number
- Z-0549-2025
- Quantity
- 100 units
- Official Source
- View on FDA website ↗
Reason for Recall
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Distribution
US Nationwide distribution in the state of TN.
Lot / Code Info
Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
Root Cause
Process change control
Action Taken
Consignees were mailed a recall notification titled URGENT ADVISORY NOTICE dated 10/30/2024. The notification instructs consignees to examine their inventory and identify all affected devices for quarantine immediately. Consignees are to complete and return the Recall Response Form to Incipio Devices at surveillance@incipiodevices.ch to facilitate the return of recalled devices and issuance of a FedEx return label. Returned devices should be sent back in their original packaging if unused and properly decontaminated and sterilized if being sent back used. Consignees with any questions should contact Incipio Devices by phone at +41 32 754 34 34 or by email at surveillance@incipiodevices.ch.