Biomet recalls StageOne Select hip stem cement spacer molds with potential insufficient cleaning process. Check lot numbers or UDI codes for affected items. Return or discard as directed by Biomet.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain StageOne Select hip stem cement spacer molds due to a potential issue with the cleaning process. This could lead to improper sterilization and infection risks for patients during surgery.
The molds may not have been cleaned properly, which could lead to contamination. This increases the risk of infection during hip surgery if the molds are used without adequate sterilization.
Patients scheduled for hip surgery using the recalled molds may be at risk. Medical professionals handling the molds during surgery could also be affected.
Check the lot numbers listed in the recall notice (e.g., 087760, 558520) or the UDI codes provided. The product is a silicone hip stem cement spacer mold used in hip surgery.
Look for the lot numbers or UDI codes listed in the recall notice to confirm if your item is affected.
The recall is due to a potential issue with the cleaning process that could lead to improper sterilization.
Check the lot numbers or UDI codes listed in the recall notice (e.g., 087760, 558520).
The recall notice 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-1646-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1646-2020 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.
