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Z-0169-2020 Class II Terminated

Recalled by OMNIlife science Inc. — Raynham, MA

FDA device recall Z-0169-2020 was initiated by OMNIlife science Inc. on September 11, 2019 and is designated Class II. Reason for recall: Stems missing porous coating on the device. The recall status is terminated (terminated April 27, 2020). Affected quantity: 3 units.

Recall Details

Product Type
Devices
Report Date
October 30, 2019
Initiation Date
September 11, 2019
Termination Date
April 27, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Product Description

OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.

Reason for Recall

Stems missing porous coating on the device.

Distribution Pattern

OK, IL

Code Information

Lot # 33035

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-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-0922-2021 Class II — SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use (December 21, 2020)
  • 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)
  • Z-2540-2018 Class II — OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Code (May 18, 2018)

FDA data resources