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OmniLife Science Recalls
17 recalls on record · August 27, 2014 to November 24, 2021 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 24, 2021Medical DevicesFDA
OmniLife Science recalls OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component
Hazard: 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.
February 3, 2021Medical DevicesFDA
OMNIlife science Inc. recalls SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for
Hazard: 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
February 3, 2021Medical DevicesFDA
OMNIlife science Inc. recalls SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup fo
Hazard: 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
February 3, 2021Medical DevicesFDA
OMNIlife science Inc. recalls SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup fo
Hazard: 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
October 30, 2019Medical DevicesFDA
OMNIlife science Inc. recalls OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primar
Hazard: Stems missing porous coating on the device.
September 11, 2019Medical DevicesFDA
OMNIlife science Inc. recalls OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10
Hazard: Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
September 11, 2019Medical DevicesFDA
OMNIlife science Inc. recalls OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28;
Hazard: Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
September 11, 2019Medical DevicesFDA
OMNIlife science Inc. recalls OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Produc
Hazard: Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
June 12, 2019Medical DevicesFDA
OMNIlife science Inc. recalls OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel sur
Hazard: The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
February 20, 2019Medical DevicesFDA
OMNIlife science Inc. recalls OMNI K1 Broach Handle, Product Code HS-10054
Hazard: There is a potential for the inner pin of the handle to become loose and fall out.
August 1, 2018Medical DevicesFDA
OMNIlife science Inc. recalls OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Prod
Hazard: The Internal packaging, the pouch and patient labels are improperly labeled.
March 28, 2018Medical DevicesFDA
OMNIlife science Inc. recalls Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a p
Hazard: 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.
September 2, 2015Medical DevicesFDA
Omnilife Science Inc. recalls Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed
Hazard: The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
September 2, 2015Medical DevicesFDA
Omnilife Science Inc. recalls Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designe
Hazard: The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
September 2, 2015Medical DevicesFDA
Omnilife Science Inc. recalls APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Ap
Hazard: The device may have improper screw hole placement due to inaccurate location of the index line.
July 22, 2015Medical DevicesFDA
Omnilife Science Inc. recalls Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral
Hazard: Product may breach the inner and outer sterile pouches during shipping or handling.
August 27, 2014Medical DevicesFDA
Omnilife Science Inc. recalls Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
Hazard: Staining on hip implant.