Home / Recalls / OMNIlife science Inc. / Z-2481-2019

Z-2481-2019 Class II Terminated

Recalled by OMNIlife science Inc. — Raynham, MA

Recall Details

Product Type
Devices
Report Date
September 11, 2019
Initiation Date
July 23, 2019
Termination Date
April 24, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6

Product Description

OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840

Reason for Recall

Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.

Distribution Pattern

US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.

Code Information

LOT # 31707

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-0920-2021 Class II — SERF Novae Dual Mobility Cup Insert 51/28- 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-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)