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OMNIlife science Inc. recalls OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28;
Recalled September 11, 2019 · FDA recall Z-2480-2019 · OMNIlife science
Hazard
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery. · FDA Class II
Units
22 units
Sold at
US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
Description
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Product
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
Manufacturer(s)
OMNIlife science Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →