Biomet recalls 70mm silicone knee cement spacer molds (Item 432170) with specific lot numbers due to potential insufficient cleaning process. Consumers should check their product's lot number to determine if affected.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain 70mm silicone knee cement spacer molds (Item 432170) because of potential issues with the cleaning process that could lead to inadequate sterilization. This recall affects specific lot numbers listed in the notice.
The recall is due to potential insufficient cleaning or inadequate monitoring of cleaning parameters during manufacturing. This could result in the mold not being properly sterilized, but the risk of injury is not described as severe or immediate.
Patients who have received this specific knee spacer mold for surgery are most at risk. The recall applies to the molds sold with specific lot numbers.
Check the lot number on the mold's packaging or label. Affected items have specific lot numbers listed in the recall notice (e.g., 606370, 049930, 959120, etc.).
Look for the lot number on the mold's packaging or label to determine if it's affected.
Biomet StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
Check the lot number on the mold's packaging or label. Affected items have specific lot numbers listed in the recall notice (e.g., 606370, 049930, 959120, etc.).
No action is required if your product's lot number is not listed in the recall notice.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1664-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1664-2020 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.
