Biomet recalls hip cement spacer molds with possible insufficient cleaning. Check lot numbers or UDI codes to see if your item is affected. Contact Biomet for details.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling hip cement spacer molds that may not have been cleaned properly during manufacturing. This could lead to contamination risks for patients during surgery. Affected items have specific lot numbers and UDI codes listed in the recall.
The molds may not have been cleaned thoroughly during manufacturing, which could lead to contamination. This poses a risk of infection or other complications during hip surgery if the molds are used without proper cleaning.
Patients undergoing hip surgery who use the recalled hip cement spacer molds. Medical professionals handling these molds during surgical procedures are also at risk.
Check the product label for lot numbers: 919110, 191510, 414530, 650030, 931530, 836760, 836740, 162280, 162260, 285580, 285590, 668840, 036370, 390550, 613860, 518830, 555610, 207250, 913770, 628380, 286980, 336640, 057600, 143950, 329700, 115650, 737870, 732050, 191510R, 836740R, 118030, 302380, 302480, 378190, 766220, 021750, 021730, 921330, 162260R, 386330, 386300, 399990, 417210, 417220, 337710, 118030R. Also check UDI codes for the specific lot numbers listed.
Look for lot numbers on the product label to see if your item is affected.
Biomet StageOne Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
Check the product label for lot numbers: 919110, 191510, 414530, 650030, 931530, 836760, 836740, 162280, 162260, 285580, 285590, 668840, 036370, 390550, 613860, 518830, 555610, 207250, 913770, 628380, 286980, 336640, 057600, 143950, 329700, 115650, 737870, 732050, 191510R, 836740R, 118030, 302380, 302480, 378190, 766220, 021750, 021730, 921330, 162260R, 386330, 386300, 399990, 417210, 417220, 337710, 118030R.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Check the product label for lot numbers to see if your item is affected. Contact Biomet for further instructions.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1656-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1656-2020 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.
