Home / Recalls / Medical Devices
INCIPIO DEVICES recalls Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Recalled December 4, 2024 · FDA recall Z-0549-2025 · INCIPIO DEVICES
Hazard
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld. · FDA Class II
Units
100 units
Sold at
US Nationwide distribution in the state of TN.
Description
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Product
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Manufacturer(s)
INCIPIO DEVICES
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →