Biomet recalls StageOne Knee Femoral Cement Spacer Mold (65mm silicone) with specific lot numbers due to potential insufficient cleaning process. Consumers should check their product's lot numbers to determine if affected.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain StageOne Knee Femoral Cement Spacer Molds (65mm silicone) because the cleaning process might not have been thorough enough. This could lead to contamination risks during surgical procedures. Affected items have specific lot numbers listed in the recall.
The recall is due to potential insufficient cleaning during the manufacturing process. This could lead to contamination risks if the molds are used in surgical procedures, though the risk is not described as causing serious injury in normal use.
Patients who received the recalled StageOne Knee Femoral Cement Spacer Molds for surgery are most at risk. The recall affects specific lot numbers used in the manufacturing process.
Check the lot number on the mold, which is listed in the recall (e.g., 410380, 036380, 095880, etc.). The product is a 65mm silicone surgical mold used in knee replacements.
Look for the lot number on the mold, which is listed in the recall (e.g., 410380, 036380, 095880, etc.).
Biomet is recalling StageOne Knee Femoral Cement Spacer Molds (65mm silicone) with specific lot numbers.
Check the lot number on the mold, which is listed in the recall (e.g., 410380, 036380, 095880, etc.).
No action is needed if your product's lot number is not listed 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-1663-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1663-2020 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.
