Biomet recalls StageOne Hip Cement Spacer Mold with Insert (60mm silicone) due to potential insufficient cleaning process. Affected items 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 Hip Cement Spacer Mold with Insert (60mm silicone) because the cleaning process might not be thorough enough. This could lead to contamination risks during medical procedures.
The mold may not be cleaned properly during manufacturing, which could lead to contamination. However, this is a medical device used in surgeries, so the risk is minimal if handled correctly by professionals.
Patients who have received this specific hip surgery mold from Biomet. The risk is low as it's a medical device used in procedures, not a consumer product.
Check for the lot numbers listed (e.g., 104420, 982400) or UDI codes starting with (01)00880304521056. The product is a silicone hip cement spacer mold used in surgeries.
Look for lot numbers or UDI codes on the product to see if it's affected.
This is a medical device used in surgeries. The recall is due to potential cleaning issues, but it's not a consumer product. If you have this mold, check the lot numbers to see if it's affected.
Check the lot numbers listed (e.g., 104420, 982400) or UDI codes starting with (01)00880304521056 on your product.
If your product has the listed lot numbers or UDI codes, contact Biomet directly for further instructions. The recall does not require immediate action for most users.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1641-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1641-2020 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.
