FDA recall Z-0549-2025

INCIPIO DEVICES · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-10-30
Report date
2024-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
St-Blaise, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0549-2025