OMNIlife science Inc. recalls OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg ho…

Recall date: July 23, 2019
Source: U.S. Food & Drug Administration (FDA) — enforcement report
Recall number: Z-2481-2019
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 ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840

Free email alert whenever OMNIlife science Inc. has a new recall — straight from official government data. Unsubscribe anytime.