Biomet recalls StageOne Knee Femoral Cement Spacer Mold (75mm silicone) with specific lot numbers due to potential insufficient cleaning process or inadequate monitoring of cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling StageOne Knee Femoral Cement Spacer Mold (75mm silicone) items with specific lot numbers because the cleaning process might not be thorough enough. This could lead to contamination risks during surgical procedures.
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, increasing the risk of contamination during surgical procedures.
Orthopedic surgeons and medical facilities using the recalled StageOne Knee Femoral Cement Spacer Mold (75mm silicone) items with the listed lot numbers. Patients are not directly affected as the recall is for medical equipment used by professionals.
Check the lot numbers listed in the recall (e.g., 593990, 240410, etc.) on the product's packaging or UDI (Unique Device Identification) label. The product is a 75mm silicone, sterile knee femoral cement spacer mold from Biomet.
Look for the lot numbers listed in the recall (e.g., 593990, 240410, etc.) on the product's packaging or UDI label.
No, this is a surgical implant mold used by orthopedic surgeons during knee replacement procedures, not directly by patients.
Check the lot numbers listed in the recall (e.g., 593990, 240410, etc.) on the product's packaging or UDI label.
The recall does not specify a remedy, so contact Biomet directly for guidance on next steps.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1665-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1665-2020 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.
