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.
Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
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.
The product is packaged in a smaller outer carton than required. This forces the Tyvex pouch to fold, creating creases that can compromise the sterile barrier. If the sterile barrier is compromised, it could lead to infection during surgery.
Patients scheduled for knee surgery using this specific implant system are affected. Surgeons and medical facilities that use the product are at risk of compromised sterile barriers.
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.
Reach out to Biomet directly for specific details about your product and instructions on next steps.
The recall indicates a potential risk to the sterile barrier, but the product is not unsafe to use if the packaging is correct.
Contact Biomet directly for specific details about your product and instructions on next steps.
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.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1018-2023 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1018-2023 from Biomet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
