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 f…

Recall date

December 21, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0921-2021

FDA classification

Class II

Brand / firm

OMNIlife science Inc.

Sold / distributed

AL, ID, MD, NY, OK

Why it was recalled

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

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

What was recalled

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