OMNIlife science Inc. recalls SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup fo

Recalled February 3, 2021 · FDA recall Z-0921-2021 · OMNIlife science

Hazard

Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery · FDA Class II

Units

3 units

Sold at

AL, ID, MD, NY, OK

Description

Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery

Product

SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728

Manufacturer(s)

OMNIlife science Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →