Biomet recalls StageOne Knee Femoral Cement Spacer Mold (60 MM, Silicone, Sterile) with specific lot numbers due to potential insufficient cleaning process. This may affect surgical implants used in knee replacements.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain StageOne Knee Femoral Cement Spacer Molds (60 MM, Silicone, Sterile) because of potential issues with the cleaning process. This could lead to improper sterilization of the surgical implant. 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, but it does not cause immediate injury or death.
Surgical patients who received the recalled molds during knee replacement procedures. The risk is low as this is a manufacturing issue that does not cause immediate harm.
Check the lot numbers listed in the recall (e.g., 584770, 095850, etc.) on the product's packaging or UDI (Unique Device Identification) label. The product is a silicone, sterile knee cement spacer mold used in surgical procedures.
Look for the lot numbers listed in the recall (e.g., 584770, 095850, etc.) on the product's packaging or UDI label.
If you have the recalled mold with the listed lot numbers, check the product's packaging or UDI label for the lot number. No action is needed if you don't have the affected lot numbers.
The recall is due to potential cleaning process issues, but the mold is not dangerous if used properly. The risk is low as this is a manufacturing issue that does not cause immediate harm.
Check the lot number on the product's packaging or UDI label against the list of affected lot numbers provided in the recall (e.g., 584770, 095850, etc.).
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1662-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1662-2020 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.
