Biomet recalls StageOne Select hip stem cement spacer molds with reinforcement cement (15x200mm silicone) due to potential insufficient cleaning. Affected items have specific lot numbers and UDI codes. Consumers should check their product details to determine if recalled.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain StageOne Select hip stem cement spacer molds with reinforcement cement (15x200mm silicone) because the cleaning process might not be thorough enough. This could lead to contamination in medical procedures if the molds are used improperly.
The recall is due to potential insufficient cleaning during manufacturing, which could leave contaminants in the mold. If the mold is used in hip replacement surgery without proper cleaning, it might introduce harmful substances into the patient's body.
Patients who have received this specific hip surgery mold for their procedure are most at risk. The recall affects medical devices used in hip replacements.
Check the lot numbers listed in the recall (e.g., 104910, 157950) or the UDI codes provided. The product is a silicone hip stem cement spacer mold used in hip replacement surgeries.
Look for the lot numbers or UDI codes on the product to see if it matches the recalled items listed in the notice.
The recall indicates a potential cleaning issue, but the product is safe for use if it has a different lot number or UDI code not listed in the recall.
Check the lot numbers or UDI codes on your product against the list provided in the recall notice.
If your product matches the recalled lot numbers or UDI codes, you should check the recall list to confirm and 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-1651-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1651-2020 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.
