SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Mo...
FDA Recall #Z-0921-2021 — Class II — December 21, 2020
Product Description
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
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
Recalling Firm
OMNIlife science Inc. — Raynham, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3 units
Distribution
AL, ID, MD, NY, OK
Code Information
Lot Number: 28624
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated