Biomet recalls StageOne Knee Tibial Cement Spacer Mold (65 MM, Silicone, Sterile) with specific lot numbers due to potential insufficient cleaning process or inadequate monitoring during manufacturing.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain StageOne Knee Tibial Cement Spacer Mold products (65 MM, Silicone, Sterile) because they may have insufficient cleaning or inadequate monitoring during production. This could lead to contamination risks for patients during surgery. Affected items have specific lot numbers listed in the recall.
The recall is due to potential insufficient cleaning process or inadequate monitoring of cleaning parameters during manufacturing. This could result in the mold not being properly sterilized, increasing the risk of contamination during surgical procedures.
Patients who have received this specific surgical mold for knee replacements are at risk. The recall targets medical devices used in orthopedic procedures, not the general public.
Check the lot numbers listed in the recall (e.g., 410520, 959170, 036440) on the product's packaging or label. The product is a 65 MM silicone surgical mold used in knee replacements.
Look for the lot number on the product's packaging or label to determine if it's affected. Affected lot numbers are listed in the recall.
If you have the affected product, contact Biomet directly for instructions on how to return or dispose of it safely.
Biomet is recalling StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
Affected lot numbers include 410520, 959170, 036440, and others listed in the recall.
Check the lot number on your product's packaging or label against the list of affected lot numbers provided in the recall.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1666-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1666-2020 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.
