OMNIlife science Inc. recalls OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Produc…
- Recall date
- July 23, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2480-2019
- 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.
What was recalled
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
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