INCIPIO DEVICES recalls Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
- Recall date
- October 30, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0549-2025
- FDA classification
- Class II
- Brand / firm
- INCIPIO DEVICES
- Sold / distributed
- US Nationwide distribution in the state of TN.
Why it was recalled
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
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