The Recall Desk

Manufacturer

Omni Life Science

7 recalls in our database name Omni Life Science as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
1
Most recent
2016-11-23

Of the 7 recalls from Omni Life Science we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (14%) 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.

1–7 of 7

  • LowFDA (Devices)·Z-0610-2017·2016-11-23

    OMNIBotics Tracker Kit Recalled for Incorrect Lot Number Labeling

    OMNI Life Science is recalling 15 OMNIBotics Tracker Kits due to incorrect lot numbers on the outer packaging.

    Product
    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.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2372-2012·2012-09-19

    Omni Life Science Recalls Apex Knee System Modular Tibia Augments

    Omni Life Science is recalling 310 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising the device's sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2374-2012·2012-09-19

    Omni Life Science Apex Knee System Modular Tibia Augment Recall

    Omni Life Science is recalling 182 units of the Apex Knee System Modular Tibia Augment because the sterile pouches may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2370-2012·2012-09-19

    Omni Life Science Recalls Apex Knee System Tibia Augments

    Omni Life Science is recalling 312 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2375-2012·2012-09-19

    Omnilife Apex Knee System Modular Tibia Augment Recalled for Sterility Breach

    Omni Life Science is recalling 36 units of Apex Knee System Modular Tibia Augments because the sterile packaging may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2371-2012·2012-09-19

    Omni Life Science Recalls Apex Knee System Modular Tibia Augments

    Omni Life Science is recalling 286 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2373-2012·2012-09-19

    Omni Life Science Apex Knee System Modular Tibia Augment Recalled for Sterility Breach

    Omni Life Science is recalling 270 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide