OMNIlife science Inc. recalls OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary o…
- Recall date
- September 11, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0169-2020
- FDA classification
- Class II
- Brand / firm
- OMNIlife science Inc.
- Sold / distributed
- OK, IL
Why it was recalled
Stems missing porous coating on the device.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
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