OMNIlife science Inc.: Medical Device Recall in 2021 - (Recall #: Z-0922-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928

Product Classification:

Class II

Date Initiated: December 21, 2020

Date Posted: February 3, 2021

Recall Number: Z-0922-2021

Event ID: 87062

Reason for Recall:

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

Status: Terminated

Product Quantity: 2 units

Code Information:

Lot Number: 28572

Distribution Pattern:

AL, ID, MD, NY, OK

Voluntary or Mandated:

Voluntary: Firm initiated