Biomet recalls StageOne Select Hip Stem Cement Spacer Mold w/Reinforcement Cement (9x125mm, silicone, sterile) due to potential insufficient cleaning process. Affected units have specific lot numbers and UDI codes. Consumers should check their product details.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling its StageOne Select Hip Stem Cement Spacer Mold with Reinforcement Cement (9x125mm, silicone, sterile) because the cleaning process might not be thorough enough. This could lead to contamination risks during medical procedures. The recall includes specific lot numbers and UDI codes.
The recall states there could be insufficient cleaning or inadequate monitoring of cleaning parameters. This might lead to contamination risks during surgical procedures, potentially causing infections or complications.
Medical professionals who use this specific hip surgery mold are most at risk. Patients using the recalled product for hip replacements may also be affected.
Check for the product name 'StageOne Select Hip Stem Cement Spacer Mold w/Reinforcement Cement', size 9x125mm, silicone, sterile. Affected units have specific lot numbers listed in the recall (e.g., 502050, 628160) or UDI codes starting with (01)00880304521995.
Look for the product name, size (9x125mm), material (silicone), and sterility status on the item.
Compare your product's lot number to the list of affected numbers provided in the recall (e.g., 502050, 628160).
Yes, this is a hip stem cement spacer mold used in hip replacement surgeries.
Check the product's lot number against the list of affected numbers provided in the recall (e.g., 502050, 628160) or UDI codes starting with (01)00880304521995.
The recall does not specify a remedy, so contact Biomet directly for guidance on next steps.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1643-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1643-2020 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.
