Class II

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

INCIPIO DEVICES · October 30, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

100 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0549-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

INCIPIO DEVICES Medical Device Recall: Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants. | SafeCheck