Biomet recalls 70mm silicone knee spacer molds (Item 433170) due to potential insufficient cleaning. Affected units have specific lot numbers; check your UDI for recall details.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain 70mm silicone knee cement spacer molds because the cleaning process might not be thorough enough. This could lead to contamination risks during surgery. If you own one of these molds, check the lot numbers listed in the recall.
The recall states there might be insufficient cleaning or inadequate monitoring of cleaning parameters. This could lead to contamination during surgical procedures, but it does not indicate immediate injury or death risks.
Surgical teams and hospitals that use these molds for knee replacements. The risk is low as the issue relates to cleaning process monitoring, not immediate harm.
Check the lot numbers listed in the recall (e.g., 809860, 273440, etc.) or the UDI numbers provided in the recall notice. The product is a 70mm silicone knee cement spacer mold, sterile, with item number 433170.
Look for the lot numbers listed in the recall (e.g., 809860, 273440, etc.) or the UDI numbers on the product.
No, the recall does not require immediate action. Check the lot numbers to see if your product is affected.
Check the lot numbers listed in the recall (e.g., 809860, 273440, etc.) or the UDI numbers on the product.
The recall does not specify a remedy, so no action is needed unless your product is listed in the lot numbers.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1667-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1667-2020 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.