Home / Recalls / OMNIlife science Inc. / Z-0920-2021

Z-0920-2021 Class II Terminated

Recalled by OMNIlife science Inc. — Raynham, MA

Recall Details

Product Type
Devices
Report Date
February 3, 2021
Initiation Date
December 21, 2020
Termination Date
June 10, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Product Description

SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128

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

Distribution Pattern

AL, ID, MD, NY, OK

Code Information

Lot Number: 28413

Other recalls by OMNIlife science Inc.

  • Z-0237-2022 Class II — OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is in (October 1, 2021)
  • Z-0922-2021 Class II — SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use (December 21, 2020)
  • Z-0921-2021 Class II — SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use (December 21, 2020)
  • Z-0169-2020 Class II — OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for (September 11, 2019)
  • Z-2479-2019 Class II — OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Ser (July 23, 2019)
  • Z-2480-2019 Class II — OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Ser (July 23, 2019)
  • Z-2481-2019 Class II — OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Ape (July 23, 2019)
  • Z-1717-2019 Class II — OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBloc (April 12, 2019)
  • Z-0837-2019 Class II — OMNI K1 Broach Handle, Product Code HS-10054 (November 29, 2018)
  • Z-2540-2018 Class II — OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Code (May 18, 2018)