Biomet recalls StageOne Hip Cement Spacer Mold with Insert (52mm silicone) due to potential insufficient cleaning process or inadequate monitoring of cleaning parameters. Lot numbers and UDI codes listed for affected units.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling its StageOne Hip Cement Spacer Mold with Insert (52mm silicone) because the cleaning process might not be thorough enough or monitoring might be inadequate. This could lead to contamination risks during hip surgery.
The mold may not be cleaned properly or the cleaning process might not be monitored correctly, which could lead to contamination during hip surgery. This is a risk for patients undergoing hip replacement procedures.
Patients who received this specific hip surgery mold during the listed production periods. Surgeons and surgical teams using the mold for hip replacements are most at risk.
Check the lot number on the mold (listed in the recall) or the UDI code (unique identifier) provided in the recall notice. The product is a silicone hip cement spacer mold used in hip replacement surgeries.
Look for the lot number or UDI code on the mold to confirm if it's affected.
The recall is due to potential insufficient cleaning or inadequate monitoring of cleaning parameters, which could lead to contamination during hip surgery. However, the risk is considered low.
Check the lot number or UDI code on the mold. Affected units have specific lot numbers and UDI codes listed in the recall notice.
Check the product details to see if it's affected. 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-1639-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1639-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
