The Recall Desk

Manufacturer

OMNIlife science Inc.

16 recalls in our database name OMNIlife science Inc. as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
3
Most recent
2021-02-03

Of the 16 recalls from OMNIlife science Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (19%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–16 of 16

  • SevereFDA (Devices)·Z-0921-2021·2021-02-03

    OMNIlife Science Recalls SERF Novae Dual Mobility Cup Inserts

    OMNIlife Science Inc. is recalling 3 units of SERF Novae Dual Mobility Cup Inserts due to high oxidation levels that may increase wear rates and require revision surgery.

    Product
    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
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0922-2021·2021-02-03

    OMNIlife Recalls SERF Novae Dual Mobility Cup Inserts Due to Oxidation

    OMNIlife science Inc. is recalling 2 units of SERF Novae Dual Mobility Cup Inserts because they have higher than acceptable oxidation limits, which may increase wear rates and require revision surgery.

    Product
    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
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0920-2021·2021-02-03

    OmnIlife Science Recalls Hip Replacement Liners Due to Oxidation Limits

    OmnIlife Science is recalling three units of SERF Novae Dual Mobility Cup Inserts because they exceed acceptable oxidation limits, potentially increasing wear rates and the need for revision surgery.

    Product
    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
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0169-2020·2019-10-30

    OMNI Hip System Femoral Component Recalled for Missing Porous Coating

    OMNIlife science Inc. is recalling three OMNI Hip System femoral components because they are missing the required porous coating.

    Product
    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.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2481-2019·2019-09-11

    OMNIlife ApeX Acetabular Liner Recalled for Oxidation Test Failure

    OMNIlife science Inc. is recalling six ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to revision surgery.

    Product
    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2480-2019·2019-09-11

    OMNIlife ApeX Acetabular Liner Recalled for Oxidation Test Failure

    OMNIlife science Inc. is recalling 22 ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to revision surgery.

    Product
    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2019·2019-09-11

    OMNIlife ApeX Acetabular Liner Recalled for Oxidation Testing Failure

    OMNIlife science Inc. is recalling 14 ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to revision surgery.

    Product
    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1717-2019·2019-06-12

    OMNIBotics iBlock Cutting Guide Recalled for Failure to Lock During Surgery

    OMNIlife science Inc. is recalling 9 OMNIBotics iBlock Cutting Guides because they may not lock onto the iBlock Saw Guide as intended and could loosen during use.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0837-2019·2019-02-20

    OMNI K1 Broach Handle Recalled Due to Loose Inner Pin Risk

    OMNIlife science Inc. is recalling seven OMNI K1 Broach Handles because the inner pin may become loose and fall out.

    Product
    OMNI K1 Broach Handle, Product Code HS-10054
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2540-2018·2018-08-01

    OMNI Hip System Acetabular Inserts Recalled for Improper Labeling

    OMNIlife science Inc. is recalling 16 units of ApeX-LNK Acetabular Inserts due to improper labeling on internal packaging and patient labels.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1117-2018·2018-03-28

    Apex Knee System Tibial Baseplate Recalled for Packaging Date Error

    OMNIlife science Inc. is recalling 32 Apex Knee System Tibial Baseplates due to an incorrect expiration date on the external packaging.

    Product
    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 us
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2455-2015·2015-09-02

    Omnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings

    Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2454-2015·2015-09-02

    Omnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings

    Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2445-2015·2015-09-02

    FDA Recalls Omnilife Apex Interface Acetabular Shells Due to Design Defect

    Omnilife Science Inc. is recalling 112 Apex Interface Hemi 54X and Flared 56X acetabular shells because improper screw hole placement may occur due to inaccurate index line location.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2064-2015·2015-07-22

    Omnilife Apex ARC Hip Stem Recalled for Sterile Pouch Breach Risk

    Omnilife Science Inc. is recalling 146 Apex ARC Hip Stems because the sterile packaging may breach during shipping or handling.

    Product
    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. Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2014·2014-08-27

    FDA Recalls Apex Arc Hip Stem Devices Due to Surface Staining

    Omnilife Science Inc. is recalling 13 Apex Arc Hip Stem devices due to staining on the implant surface.

    Product
    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
    Category
    Medical Device
    Distribution
    7 states