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Lower risk Medical device recall · FDA · Published December 15, 2022

Biomet Oxford Partial Knee System Recall: Incorrect Packaging May Compromise Sterile

Biomet recalls Oxford Partial Knee System due to incorrect packaging that may compromise sterile barrier. Affected items have smaller outer carton causing folded Tyvex pouches. Consumers should contact Biomet for details.

🇺🇸 FDA recall #Z-1018-2023Medical deviceBiomet ›
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Recalling firmBiomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989
✎ GovInfoNow plain-language explainer

Biomet is recalling its Oxford Partial Knee System because the packaging may be incorrect, causing the sterile barrier to be compromised. This could lead to infection or other complications during surgery. Read more at govinfonow.com/recall/59120-biomet-oxford-partial-knee-system-recall-incorrect-packaging-may-compromise.

Source Summary by GovInfoNow · govinfonow.com/recall/59120-biomet-oxford-partial-knee-system-recall-incorrect-packaging-may-compromise · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1018-2023

Cite this page

“Biomet Oxford Partial Knee System Recall: Incorrect Packaging May Compromise Sterile.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59120-biomet-oxford-partial-knee-system-recall-incorrect-packaging-may-compromise. Based on FDA recall #Z-1018-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1018-2023%22&limit=1).

The FDA announced on 2022-12-15 that Biomet, Inc. is recalling the Oxford Partial Knee System due to packaging errors that compromise the sterile barrier. The agency issued recall number Z-1018-2023 for the Class II device.

How to tell if you have it

  • Brand: Biomet
  • Product: Oxford Partial Knee System, Fixed Lateral Tibial Construct
  • Item Number: 154341
  • UPC: 05019279515349
  • Lot Number: 077830

The hazard

The device was packaged in an incorrect shelf carton. The outer carton is smaller than required, forcing the Tyvex pouch to fold and creating compound creases that compromise the sterile barrier.

Context

GovInfoNow's records show Biomet, Inc. has had 28 other recalls since 2018-02-28. Recent brand recalls include a 2026-07-01 Intramedullary Bone Saw Blade recall for potential packaging damage and a 2025-09-23 ZipT recall for a missing button risk. Other recent recalls of similar products include Medline Convenience Kits recalls (2026-06-12) and a Medline Eye Kits recall (2026-06-12).

How to tell if you have this one

Check for item number 154341 and lot number 077830 on the packaging. The outer carton is smaller than the required size, causing the Tyvex pouch to fold.

  • Brand
    Biomet
  • Product
    Oxford Partial Knee System, Fixed Lateral Tibial Construct
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact Biomet

    Reach out to Biomet directly for specific details about your product and instructions on next steps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of IN, KY and the countries of Canada, New Zealand, Japan, Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Indiana, Kentucky.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Dec 15, 202212. FDA classified it Class II: Jan 26, 202323. Published in FDA’s Enforcement Report: Feb 1, 2023320222023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates a potential risk to the sterile barrier, but the product is not unsafe to use if the packaging is correct.

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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-1018-2023 (December 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1018-2023 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA