Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.

Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.

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 [email protected] 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 [email protected].