Medical device recalls Moderate risk

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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