OMNIlife science Inc. recalls OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code:…

Recall date: July 23, 2019
Source: U.S. Food & Drug Administration (FDA) — enforcement report
Recall number: Z-2479-2019
FDA classification: Class II
Brand / firm: OMNIlife science Inc.
Sold / distributed: US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.

Why it was recalled

Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328

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