Biomet recalls StageOne Select hip stem cement spacer molds with reinforcement cement (item 431195) due to potential insufficient cleaning processes. Affected units have specific lot numbers and UDI codes. Consumers should check their product details and contact Biomet for guidance.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling StageOne Select hip stem cement spacer molds with reinforcement cement (item 431195) because the cleaning process might not be thorough enough. This could lead to contamination or infection risks during medical procedures. The recall affects specific units with listed lot numbers and UDI codes.
The recall is due to potential insufficient cleaning processes or inadequate monitoring of cleaning parameters. This could result in contamination of the molds, increasing the risk of infection during surgical procedures.
Medical professionals who use these molds for hip replacements are most at risk. The recall applies to specific units with the listed lot numbers and UDI codes.
Check the product label for the lot numbers listed (e.g., 978870, 104900) or the UDI codes (e.g., (01)00880304521124(17)160628(10)978870). The product is a silicone hip stem cement spacer mold with reinforcement cement, item 431195.
Look for the lot numbers or UDI codes on the product label to confirm if it's affected.
The recall is due to potential insufficient cleaning processes or inadequate monitoring of cleaning parameters, which could lead to contamination.
Check the product label for lot numbers like 978870 or UDI codes such as (01)00880304521124(17)160628(10)978870.
Contact Biomet directly for guidance on next steps; the recall does not include a specific remedy.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1648-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1648-2020 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.
