Biomet recalls 80mm silicone knee spacer molds with potential insufficient cleaning. Affected models include specific lot numbers. Consumers should check their product for matching lot numbers and contact Biomet for details.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain StageOne Knee Tibial Cement Spacer Mold products due to potential issues with the cleaning process. This could lead to inadequate cleaning of the molds, though the specific risk is not described as causing injury or harm in normal use. Affected products have specific lot numbers listed in the recall.
The recall states there is a potential for insufficient cleaning process or inadequate monitoring of cleaning parameters. This could result in the mold not being properly cleaned, but the specific risk of injury or harm is not described in the recall notice.
Medical professionals who use Biomet StageOne Knee Tibial Cement Spacer Molds for surgical procedures. The risk is low as the hazard involves potential cleaning process issues but does not indicate a risk of injury or harm in normal use.
Check the product for the lot numbers listed: 164050, 200280, 200310, 792540, 417400, and other specific numbers provided in the recall. Also look for the UDI numbers starting with (01)00880304007031.
Look for the lot numbers listed in the recall: 164050, 200280, 200310, 792540, 417400, and other specific numbers provided in the recall.
Biomet StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
The affected lot numbers include 164050, 200280, 200310, 792540, 417400, and many others listed in the recall.
The recall states there is a potential for insufficient cleaning process or inadequate monitoring of cleaning parameters, but it does not describe a risk of injury or harm in normal use.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1669-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1669-2020 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.
