Biomet recalls StageOne Select Hip Stem Cement Spacer Mold w/Reinforcement Cement (11 X 200 MM, Silicone, Sterile) with specific lot numbers due to potential insufficient cleaning process or inadequate monitoring of cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain StageOne Select Hip Stem Cement Spacer Mold products for hip surgery due to potential issues with the cleaning process. This could lead to inadequate cleaning of the mold, which might affect the safety of the surgical procedure.
The recall is due to potential insufficient cleaning process or inadequate monitoring of cleaning parameters during manufacturing. This could result in the mold not being cleaned properly, which might lead to contamination or other issues during surgical procedures.
Orthopedic surgeons and medical facilities that use the recalled hip stem cement spacer molds for surgical procedures. Patients using these molds during hip surgery may be at risk if the molds are not properly cleaned.
Check the lot numbers listed in the recall notice (e.g., 188860, 326860, 558630, etc.) or the UDI numbers provided. The product is a silicone hip stem cement spacer mold used in hip surgery.
Look for the lot numbers listed in the recall notice (e.g., 188860, 326860, 558630, etc.) on the product or its packaging.
Biomet StageOne Select Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
Lot numbers 188860, 326860, 558630, and other specific numbers listed in the recall notice.
Check the lot numbers on the product or its packaging against the list provided in the recall notice.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1649-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1649-2020 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.
