FDA-Device2024-12-04Class II
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
INCIPIO DEVICES
Hazard
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Sold states
US Nationwide distribution in the state of TN.
Affected count
100 units
Manufactured in
avenue des Paquiers 16, St-Blaise, Switzerland
Products
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0549-2025Don't want to check this manually?
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