The Recall Desk

Manufacturer

OmniLife Science

1 recall in our database name OmniLife Science as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2021-11-24

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

1–1 of 1

  • HighFDA (Devices)·Z-0237-2022·2021-11-24

    Hip implant stem missing surface treatment affecting seven units

    OmniLife Science is recalling 7 units of the OMNI K2 Hip Stem due to missing grit blasting on the proximal surface, a defect that could lead to implant loosening and revision surgery. The recall affects units distributed to Colorado and Virginia.

    Product
    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 single use implantation.
    Category
    Medical Device
    Distribution
    2 states