Raynham, MA, United States
OMNIlife science Inc. recalls
8 recalls recorded since 2018, most recently on 1 October 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)0
Terminated or completed8
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 1 October 2021
- Terminated
- 20 July 2022
- Reason
- The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
- Distribution
- US Distribution to states of: Colorado and Virginia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0237-2022
- OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and si
Terminated Class II Medical devices
- Recall started
- 21 December 2020
- Terminated
- 10 June 2021
- Reason
- Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
- Distribution
- AL, ID, MD, NY, OK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0922-2021, Z-0920-2021, Z-0921-2021
- SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
- SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128
- SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728
Terminated Class II Medical devices
- Recall started
- 11 September 2019
- Terminated
- 27 April 2020
- Reason
- Stems missing porous coating on the device.
- Distribution
- OK, IL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0169-2020
- 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.
Terminated Class II Medical devices
- Recall started
- 23 July 2019
- Terminated
- 24 April 2020
- Reason
- Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
- Distribution
- US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2480-2019, Z-2481-2019, Z-2479-2019
- OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
- OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
- OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
Terminated Class II Medical devices
- Recall started
- 12 April 2019
- Terminated
- 14 May 2020
- Reason
- The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
- Distribution
- US Nationwide distribution in the states of OK, SC, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1717-2019
- 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
Terminated Class II Medical devices
- Recall started
- 29 November 2018
- Terminated
- 16 April 2020
- Reason
- There is a potential for the inner pin of the handle to become loose and fall out.
- Distribution
- The products were distributed to the following US states: CA, GA, SC, and UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0837-2019
- OMNI K1 Broach Handle, Product Code HS-10054
Terminated Class II Medical devices
- Recall started
- 18 May 2018
- Terminated
- 28 January 2019
- Reason
- The Internal packaging, the pouch and patient labels are improperly labeled.
- Distribution
- US Nationwide Distribution - in the states of AZ, CA, CO, IL, FL & MA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2540-2018
- OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femor
Terminated Class II Medical devices
- Recall started
- 20 November 2017
- Terminated
- 7 June 2019
- Reason
- The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.
- Distribution
- Worldwide Distribution - US Distribution and to the country Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1117-2018
- Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fix
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.