Home / Recalls / OMNIlife science Inc. / Z-1717-2019

Z-1717-2019 Class II Terminated

Recalled by OMNIlife science Inc. — Raynham, MA

Recall Details

Product Type
Devices
Report Date
June 12, 2019
Initiation Date
April 12, 2019
Termination Date
May 14, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9

Product Description

OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit, and for preparation of the bone for implant implantation. The instrument has been designed to facilitate bone preparation and implantation of the OMNI Apex Knee System.

Reason for Recall

The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.

Distribution Pattern

US Nationwide distribution in the states of OK, SC, and WI.

Code Information

MI1218

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