Biomet recalls StageOne Select Hip Stem Cement Spacer Mold w/Reinforcement Cement (11 X 135 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 due to potential issues with the cleaning process. This could lead to inadequate cleaning, but the recall does not specify any immediate safety risks or injuries. Affected customers should check their product's lot numbers to see if they are included in the recall.
The recall indicates that the cleaning process for these medical devices might not have been sufficiently thorough or monitored properly. This could result in inadequate cleaning, but the official notice does not specify any immediate safety risks or injuries.
Medical professionals who use Biomet StageOne Select Hip Stem Cement Spacer Mold products for hip surgeries are most at risk. The recall applies to specific lot numbers listed in the official notice.
Check the lot numbers listed in the official recall notice (e.g., 996010, 795510, 603900, etc.) on the product's packaging or label. The product is a silicone, sterile hip stem cement spacer mold used in hip surgeries.
Look for the lot number on the product's packaging or label to determine if it is included in the recall list (e.g., 996010, 795510, 603900, etc.).
Biomet StageOne Select Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile.
The recall includes specific lot numbers listed in the official notice (e.g., 996010, 795510, 603900, etc.).
The recall states potential insufficient cleaning process or inadequate monitoring of cleaning parameters, but does not specify any immediate safety risks or injuries.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1644-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1644-2020 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.
