Lower risk Medical device recall · FDA · Published November 20, 2017

OMNIlife Apex Knee System: Improper Expiration Date on Packaging

OMNIlife recalls Apex Knee System Tibial Baseplate Size 6 Left (KC-2206L) due to improper expiration date marked on external packaging. The correct expiration date is 2022-03, but the external packaging shows 2202-03. This may affect product safety.

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

🇺🇸 FDA recall #Z-1117-2018Medical device OMNIlife ›

Lower-risk recall

The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.

Take action

Contact the company

Recalling firmOMNIlife science Inc.480 Paramount Dr · Raynham, MA 02767-1085

✎ GovInfoNow plain-language explainer

OMNIl:ife recalls a specific knee replacement component (Tibial Baseplate Size 6 Left) because the external packaging has an incorrect expiration date (2202-03) instead of the correct 2022-03. This could lead to improper use of the implant if the expiration date is misinterpreted. Read more at govinfonow.com/recall/72514-omnilife-apex-knee-system-improper-expiration-date-on-packaging.

Source Summary by GovInfoNow · govinfonow.com/recall/72514-omnilife-apex-knee-system-improper-expiration-date-on-packaging · Updated September 1, 2026 · FDA enforcement record: FDA #Z-1117-2018

Cite this page

“OMNIlife Apex Knee System: Improper Expiration Date on Packaging.” GovInfoNow, updated September 1, 2026. https://govinfonow.com/recall/72514-omnilife-apex-knee-system-improper-expiration-date-on-packaging. Based on FDA recall #Z-1117-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1117-2018%22&limit=1).

The FDA announced on 2017-11-20 that OMNIlife science Inc. is recalling the Apex Knee System Tibial Baseplate Size 6 Left due to an improper expiration date marked on external packaging. The agency issued recall number Z-1117-2018 for the Class II device.

How to tell if you have it

Brand: OMNIlife
Product: Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L
Lot #: 26519
Distribution: US and Spain

The hazard

The external packaging of the Apex Knee System Tibial Baseplate displays an incorrect expiration date of 2202-03. The correct lot number 2022-03 is present in the internal packaging and sterile batch documentation.

Context

GovInfoNow's records show OMNIlife science Inc. has 6 other recalls on record since 2018-05-18. Other recent recalls of similar products include Miach BEAR Implant Model 1000 (2025-12-31), Expressaire Disposable Tourniquet Cuff Recall (2026-08-24), and Cardinal Health ChemoPlus Gowns Recall (2025-11-12).

How to tell if you have this one

Check for the product code KC-2206L on the external packaging. The specific component is a Tibial Baseplate Size 6 Left, non-porous, used in knee replacements. The external packaging shows an expiration date of 2202-03 instead of the correct 2022-03.

Brand
OMNIlife
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Packaging Dates
Verify the expiration date on the external packaging is 2022-03, not 2202-03.

How this recall unfolded

Recall timeline

FDA terminated this recall 19 months after the firm started it.

Nov 20, 2017Firm started the recall
Mar 19, 2018FDA classified it Class II
Mar 28, 2018Published in FDA’s Enforcement Report
Jun 7, 2019FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/72514-omnilife-apex-knee-system-improper-expiration-date-on-packaging">OMNIlife Apex Knee System: Improper Expiration Date on Packaging (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-1117-2018 (November 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1117-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 1, 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.