Biomet recalls EU version of ARTHROSIMPLICITY surgical kit (item 24-4055) due to potential unsterilized components. Affected kits include specific lot numbers. Consumers should contact Biomet for details.
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Biomet is recalling a specific EU version of the ARTHROSIMPLICITY surgical kit because it may not have been properly sterilized. This could lead to infection risks during surgery if the kit is used. The recall affects kits with certain lot numbers.
The kit may not have been properly sterilized due to alignment issues with the gamma sterilization process. This means the surgical instruments could be contaminated with harmful bacteria, increasing the risk of infection during procedures.
Surgical professionals and hospitals that purchased the Biomet ARTHROSIMPLICITY kit with EU item number 24-4055 and specific lot numbers (894660A, 894660B, 894670B, 894700B) are affected. The risk is highest for those using the kit in procedures where sterilization is critical.
Check for the EU item number 24-4055 on the kit. Affected kits have lot numbers 894660A, 894660B, 894670B, or 894700B. The recall applies to kits sold in Europe.
Identify the lot number on the kit's packaging to see if it matches the affected numbers: 894660A, 894660B, 894670B, or 894700B.
The kit may not have been properly sterilized due to alignment issues with the gamma sterilization process, which could lead to contamination.
Check the lot number on the kit. If it matches the affected numbers, contact Biomet for instructions on how to handle the kit.
Yes, if the kit is used without proper sterilization, it could lead to infections during surgery.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0084-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0084-2021 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.
