Biomet recalls StageOne Hip Cement Spacer Mold with Insert (48mm silicone) due to potential insufficient cleaning process. Affected items have specific lot numbers; contact Biomet for details.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling StageOne Hip Cement Spacer Mold with Insert (48mm silicone) because the cleaning process might not be thorough enough. This could lead to contamination risks during hip surgery. If you have this product, stop using it and contact Biomet for instructions.
The mold might not be cleaned properly during production, which could lead to contamination. However, this is a manufacturing defect and not an immediate safety risk during use.
Patients who have received this hip surgery mold for their implant. The risk is low as it's a manufacturing issue, not a direct safety hazard.
Check the product label for lot numbers: 623210, 636020, 822620, 865060, 823110, 922950, 234200, 556590, 801160, 919620, 115650, 401230, 382910, 508910, 189900, 534730, 009800, 280090, 844520, 297620, 554620, 744820, 431230, 913690, 940260, 745380, 981490, 251350, 364310, 675220, 940100, 990100, 327990, 396630, 903720, 295160, 374220, 679700, 679710, 716140, 952890, 496420, 496430, 820430, 816090, 921260, 496440, 496460, 038620, 292650, 441830, 362260, 683620, 966920, 829800, 949730, 591230, 988900, 988910, 826960, 757380, 757390, 757400, 826970, 893670, 826990, 757410, 826930, 893720, 893710, 808600, 778290, 915190, 808580, 884480, 884490, 920520, 920530, 920540, 920530R, 455880, 455900, 696930, 737370, 737380, 455910, 569270, 569280, 569290, 569300, 569320, 569330, 569340, 569360, 569370, 569380, 696800, 696820, 696830, 696840, 696850, 696860, 696890, 696900, 696910, 765040, 765050, 765060, 765070, 765080, 672450, 672460, 672640, 672650, 672770, 737700, 672480, 696920, 694950, 694960, 671920, 672000.
Look for lot numbers listed in the recall notice to determine if your item is affected.
Reach out to Biomet directly for instructions on what to do next if your item is affected.
No, this is a manufacturing issue with the cleaning process, not an immediate safety hazard. The risk is low.
Check the product label for lot numbers from the list provided in the recall notice.
Contact Biomet directly for instructions on what to do next.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1638-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1638-2020 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.
