Recall Z-0549-2025 ยท HWA Impactor
INCIPIO DEVICES
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
| Date | Nov 25, 2024 (initiated Oct 30, 2024) |
| Status | Open, Classified |
| Reason | Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld. |
| Root cause | Process change control |
| Action | 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 c |
| Quantity | 100 units |
| Distribution | US Nationwide distribution in the state of TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.