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Recall Observatory FDA recall evidence

Device product

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

Z-0549-2025

October 30, 2024

Class II

Product summary

Firm
INCIPIO DEVICES
Event
Event 95653
Status
Ongoing
Classification
Class II
Quantity
100 units
Official record key
device-enforcement:Z-0549-2025

Official wording

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

Code information: Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.

Distribution pattern: US Nationwide distribution in the state of TN.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    does not meet specification