Lower risk Medical device recall · FDA · Published October 1, 2021

OmniLife Science OMNI K2 Hip Stem Recall: Missing Grit Blasting Risk

OmniLife Science recalls OMNI K2 Hip Stem (Product Code 130006) due to missing grit blasting on the proximal surface, which may cause undersizing during hip replacement surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0237-2022Medical device OmniLife Science ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmOmniLife Science480 Paramount Dr · Raynham, MA 02767-1085

✎ GovInfoNow plain-language explainer

OmniLife Science is recalling its OMNI K2 Hip Stem (Product Code 130006) because it lacks grit blasting on the proximal surface. This could lead to the hip stem being too small during surgery, requiring revision. Patients with this implant should contact the manufacturer for guidance. Read more at govinfonow.com/recall/61726-omnilife-science-omni-k2-hip-stem-recall-missing-grit-blasting.

Source Summary by GovInfoNow · govinfonow.com/recall/61726-omnilife-science-omni-k2-hip-stem-recall-missing-grit-blasting · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0237-2022

Cite this page

“OmniLife Science OMNI K2 Hip Stem Recall: Missing Grit Blasting Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61726-omnilife-science-omni-k2-hip-stem-recall-missing-grit-blasting. Based on FDA recall #Z-0237-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0237-2022%22&limit=1).

OmniLife Science voluntarily recalled the OMNI K2 Hip Stem on Oct. 1, 2021, according to the FDA. The device lacks grit blasting on the proximal surface, which may lead to product revision due to undersizing.

How to tell if you have it

Brand: OmniLife Science
Product: OMNI K2 Hip Stem
Manufacturer's Product Code: 130006
UDI: 00841690102496
Lot: 38933
Quantity: 7 units
Distribution: Colorado and Virginia

The hazard

The OMNI K2 Hip Stem is missing grit blasting on the proximal surface of the femoral stem. This defect may lead to the possibility of product revision in the event of undersizing.

Context

GovInfoNow's records show other recent recalls of similar products include Howmedica OMNIFIT Series I Acetabular Insert Recall (2026-07-30) and Zeiss Intrabeam Spherical Applicator 1.5 cm Recall (2026-06-01). Howmedica Osteonics Recalls Hip Implant Components Due to Oxidation Risk was reported on 2026-07-30.

How to tell if you have this one

Check for the product code 130006 on the hip stem. The recall applies to the OMNI K2 Hip Stem used in primary total hip replacements with UDI 00841690102496 and Lot 38933.

Brand
OmniLife Science
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to OmniLife Science directly for guidance on next steps regarding your implant.

Where it went and when

Where it was distributed

Distributed in Colorado and Virginia.

FDA distribution: “US Distribution to states of: Colorado and Virginia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Colorado, Virginia.

Recall timeline

FDA terminated this recall 10 months after the firm started it.

Oct 1, 2021Firm started the recall
Nov 16, 2021FDA classified it Class II
Nov 24, 2021Published in FDA’s Enforcement Report
Jul 20, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall dangerous?

The recall indicates a potential risk of undersizing during surgery, but it does not describe a risk of serious injury or death in normal use.

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Link to this recall

<a href="https://govinfonow.com/recall/61726-omnilife-science-omni-k2-hip-stem-recall-missing-grit-blasting">OmniLife Science OMNI K2 Hip Stem Recall: Missing Grit Blasting Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0237-2022 (October 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0237-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.