Biomet recalls certain StageOne Shoulder Cement Spacer Mold 12 MM units due to potential insufficient cleaning process or inadequate monitoring of cleaning parameters. Affected items have specific lot numbers and UDI codes.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling specific models of Shoulder Cement Spacer Mold 12 MM for potential cleaning process issues. This could lead to inadequate sterilization, though the exact risk is not specified in the recall notice.
The recall states there might be insufficient cleaning or inadequate monitoring of cleaning parameters. This could result in the mold not being properly sterilized, but the recall does not specify a risk of injury or infection.
Medical professionals who use these molds for shoulder cement spacers during surgery. The risk is low as the hazard relates to potential cleaning process issues rather than immediate safety hazards.
Check for the product name 'Biomet StageOne Shoulder Cement Spacer Mold 12 MM' with specific lot numbers listed in the recall (e.g., 860910, 215450). Also look for UDI numbers starting with (01)00880304551008.
Identify the lot number or UDI code on the product to see if it matches the listed numbers in the recall.
The recall states there might be insufficient cleaning process or inadequate monitoring of cleaning parameters, which could lead to the mold not being properly sterilized.
Check the lot number or UDI code on the product against the list provided in the recall (e.g., 860910, 215450, or UDI numbers starting with (01)00880304551008).
The recall does not specify a remedy, so contact Biomet directly for further instructions.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1660-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1660-2020 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.
