Biomet recalls StageOne Hip Cement Spacer Mold with Insert (56mm silicone) due to potential insufficient cleaning process. Lot numbers and UDI codes listed. Consumers should check their product details.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling StageOne Hip Cement Spacer Mold with Insert (56mm 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, potentially leaving contaminants that could affect the surgical site. However, this is a production issue, not an immediate safety risk.
Patients who received this specific hip implant mold during surgery. The risk is low as it's a manufacturing issue, not a direct safety hazard.
Check for the product name 'StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile' and lot numbers listed in the recall (e.g., 082090, 651800). Also look for UDI codes starting with (01)00880304521254.
Look for the product name and lot numbers listed in the recall to confirm if your item is affected.
No, this is a manufacturing issue that could lead to contamination during surgery, but it's not an immediate safety hazard.
Check the product name and lot numbers listed in the recall (e.g., 082090, 651800). Also look for UDI codes starting with (01)00880304521254.
Check if your product is listed in the recall. If it is, contact Biomet 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-1640-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1640-2020 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.
