BEUDAMED
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    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328

    FDA Enforcement
    Class II ·Terminated·OMNIlife science Inc.·September 11, 2019

    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128

    FDA Enforcement
    Class II ·Terminated·OMNIlife science Inc.·September 11, 2019

    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840

    FDA Enforcement
    Class II ·Terminated·OMNIlife science Inc.·September 11, 2019

    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LZO·July 23, 2019

    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LZO·July 23, 2019

    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LPH·July 23, 2019

    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 femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Congenital dislocation Revision procedures where other treatments or devices have failed

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LPH·May 18, 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 fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed.

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code JWH·November 20, 2017

    OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty

    FDA Recall
    Terminated ·OMNI LIFE SCIENCE·Product code OLO·October 14, 2016

    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.

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code OLO·April 12, 2019

    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.

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LPH·September 11, 2019

    Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems

    FDA Recall
    Terminated ·Omnilife Science Inc.·Product code FZX·June 9, 2015

    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

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LZO·December 21, 2020

    OMNI K1 Broach Handle, Product Code HS-10054

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LXH·November 29, 2018

    Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems

    FDA Recall
    Terminated ·Omnilife Science Inc.·Product code FZX·June 9, 2015

    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.

    FDA Recall
    Terminated ·Omnilife Science Inc.·Product code LPH·June 4, 2015

    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

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LZO·December 21, 2020

    Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)

    FDA Recall
    Terminated ·Omnilife Science Inc.·Product code LZO·June 3, 2015

    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA

    FDA Recall
    Terminated ·Omnilife Science Inc.·Product code LZO·May 9, 2014

    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

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LZO·December 21, 2020