Biomet recalls specific silicone shoulder cement spacer molds due to potential insufficient cleaning processes. Affected items have unique lot numbers and UDI codes.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain silicone shoulder cement spacer molds that may not have been cleaned properly during manufacturing. This could lead to contamination risks for patients during surgery.
The molds may not have been cleaned thoroughly during manufacturing, potentially leaving contaminants that could affect surgical outcomes. This is a manufacturing issue rather than a user error.
Surgical patients who received the recalled shoulder cement spacer molds during procedures. Medical professionals using these molds for surgeries are most at risk.
Check for the specific lot numbers listed in the recall notice or the UDI codes provided. These molds are used in shoulder surgeries and are sterile.
Look for the lot numbers or UDI codes listed in the recall notice to confirm if your mold is affected.
The recall is due to potential insufficient cleaning processes during manufacturing, which could leave contaminants.
Check for the specific lot numbers or UDI codes listed in the recall notice.
The recall notice does not provide a remedy, so affected items should be checked for the specific lot numbers.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1661-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1661-2020 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.
