Biomet recalls StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175 due to potential insufficient cleaning process or inadequate monitoring of cleaning parameters. Affected units have specific lot numbers and UDI codes listed in the recall.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain StageOne Knee Tibial Cement Spacer Mold products (75 MM, silicone, sterile) because the cleaning process might not have been thorough enough. This could lead to contamination risks during surgical procedures. If you own one of these molds, you should check the lot numbers listed in the recall.
The recall is due to potential insufficient cleaning or inadequate monitoring of cleaning parameters during manufacturing. This could result in contamination of the molds, which are used in surgical procedures. However, the hazard is not described as causing serious injury or death in normal use.
Patients and medical professionals who use these molds for knee surgeries are most at risk. The recall affects specific lot numbers and UDI codes listed in the notice.
Check the lot numbers listed in the recall (e.g., 810230, 273520, 585000) and UDI codes (e.g., (01)00880304002647(17)201028(10)810230) on the product. The product is a silicone, sterile, 75 MM knee tibial cement spacer mold with item number 433175.
Look for the lot numbers and UDI codes listed in the recall on the product to determine if it's affected.
Biomet is recalling StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
Affected lot numbers include 810230, 273520, 585000, and others listed in the recall notice.
Check the lot numbers and UDI codes on the product against the list provided 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-1668-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1668-2020 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.
