Home / Recalls / Omnilife Science Inc. / Z-2445-2015

Z-2445-2015 Class II Terminated

Recalled by Omnilife Science Inc. — East Taunton, MA

FDA device recall Z-2445-2015 was initiated by Omnilife Science Inc. on June 4, 2015 and is designated Class II. Reason for recall: The device may have improper screw hole placement due to inaccurate location of the index line. The recall status is terminated (terminated September 28, 2015). Affected quantity: 112.

Recall Details

Product Type
Devices
Report Date
September 2, 2015
Initiation Date
June 4, 2015
Termination Date
September 28, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
112

Product Description

APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.

Reason for Recall

The device may have improper screw hole placement due to inaccurate location of the index line.

Distribution Pattern

US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.

Code Information

H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097

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-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)

FDA data resources