Biomet recalls StageOne Shoulder Cement Spacer Mold 8 MM (Item 431408) due to potential insufficient cleaning process. Affected units have specific lot numbers and UDI codes. Consumers should check their product details.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling its StageOne Shoulder Cement Spacer Mold 8 MM (Item 431408) because the cleaning process might not be thorough enough. This could lead to contamination risks if the mold is used in medical procedures. The recall affects specific units with listed lot numbers and UDI codes.
The recall is due to potential insufficient cleaning or inadequate monitoring of cleaning parameters during manufacturing. This could result in contamination if the mold is used in medical procedures, but the risk is not severe in normal use.
Medical professionals who use this mold for shoulder cement spacers during surgery are most at risk. The recall applies to specific units with the listed lot numbers and UDI codes.
Check the product for lot numbers listed in the recall (e.g., 860710, 215430) or UDI codes starting with (01)00880304551015(17).
Look for lot numbers or UDI codes on the product to determine if it's affected.
The recall indicates potential cleaning issues, but the product is safe to use if it's not in the affected lot numbers or UDI codes.
Check the product for lot numbers listed in the recall (e.g., 860710, 215430) or UDI codes starting with (01)00880304551015(17).
The recall does not specify a remedy, so affected units should be checked for safety and disposed of if necessary.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1658-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1658-2020 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.
