Home / Recalls / Omnilife Science Inc. / Z-2064-2015

Z-2064-2015 Class II Terminated

Recalled by Omnilife Science Inc. — East Taunton, MA

Recall Details

Product Type
Devices
Report Date
July 22, 2015
Initiation Date
June 3, 2015
Termination Date
September 8, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
146 devices

Product Description

Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)

Reason for Recall

Product may breach the inner and outer sterile pouches during shipping or handling.

Distribution Pattern

US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.

Code Information

Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070

Other recalls by Omnilife Science Inc.

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  • Z-0922-2021 Class II — SERF Novae Dual Mobility Cup Insert 49/28-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-2481-2019 Class II — OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Ape (July 23, 2019)
  • Z-2480-2019 Class II — OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Ser (July 23, 2019)
  • Z-2479-2019 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)