Biomet recalls hip cement spacer molds with specific lot numbers due to potential insufficient cleaning processes. Affected items may have inadequate cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling hip cement spacer molds that could have insufficient cleaning processes, potentially leading to inadequate cleaning parameters. This affects patients who have received these molds during surgery.
The molds may not have been cleaned properly during manufacturing, which could lead to inadequate cleaning parameters. This might result in the presence of contaminants that could affect surgical outcomes.
Patients who received the recalled hip cement spacer molds during surgery. Medical professionals using the molds for surgical procedures are also affected.
Check the lot numbers listed in the recall notice: 004800, 104440, 734050, 082110, 912150, 961960, 092470, 630170, 602290, 357210, 508930, 474100, 913740, 364330, 396650, 295210, 854280, 952930, 816110, 362340, 184510, 988980, 988960, 827160, 362340R, 231990, 232110, 757770, 757640, 827170, 757740, 757700, 118590, 118580, 884570, 913740R, 455920, 569510, 396650R, 740650, 800090, 911390, 926010, 118580R, 911440, 911480, 925990, 926000, 926040, 868260, 911470, 926050, 464210. Also check the UDI numbers provided in the recall notice.
Look for the lot numbers listed in the recall notice: 004800, 104440, 734050, 082110, 912150, 961960, 092470, 630170, 602290, 357210, 508930, 474100, 913740, 364330, 396650, 295210, 854280, 952930, 816110, 362340, 184510, 988980, 988960, 827160, 362340R, 231990, 232110, 757770, 757640, 827170, 757740, 757700, 118590, 118580, 884570, 913740R, 455920, 569510, 396650R, 740650, 800090, 911390, 926010, 118580R, 911440, 911480, 925990, 926000, 926040, 868260, 911470, 926050, 464210.
Biomet StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
Lot numbers: 004800, 104440, 734050, 082110, 912150, 961960, 092470, 630170, 602290, 357210, 508930, 474100, 913740, 364330, 396650, 295210, 854280, 952930, 816110, 362340, 184510, 988980, 988960, 827160, 362340R, 231990, 232110, 757770, 757640, 827170, 757740, 757700, 118590, 118580, 884570, 913740R, 455920, 569510, 396650R, 740650, 800090, 911390, 926010, 118580R, 911440, 911480, 925990, 926000, 926040, 868260, 911470, 926050, 464210.
Check the lot numbers listed in the recall notice: 004800, 104440, 734050, 082110, 912150, 961960, 092470, 630170, 602290, 357210, 508930, 474100, 913740, 364330, 396650, 295210, 854280, 952930, 816110, 362340, 184510, 988980, 988960, 827160, 362340R, 231990, 232110, 757770, 757640, 827170, 757740, 757700, 118590, 118580, 884570, 913740R, 455920, 569510, 396650R, 740650, 800090, 911390, 926010, 118580R, 911440, 911480, 925990, 926000, 926040, 868260, 911470, 926050, 464210.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1642-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1642-2020 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.
