Biomet recalls surgical tray product code 246111003 due to failed steam sterilization validation. All units are affected. Consumers should contact Biomet for details.
Device and tray that houses the device did not pass steam sterilization process validation testing
Biomet is recalling all units of their Screw Instrument Tray 6.5/80MM (product code 246111003) because it didn't pass steam sterilization testing. This could lead to improper sterilization of surgical instruments, posing a risk of infection during procedures.
The tray failed steam sterilization validation testing, meaning it may not properly kill all microorganisms. This could lead to contaminated instruments if used in surgery without proper sterilization.
Surgical professionals and hospitals that use this specific tray model are affected. The risk is low for end-users since the tray is used in controlled medical settings.
Check for the product code 246111003 on the tray. All lots of this specific surgical tray model are included in the recall.
Reach out to Biomet directly for specific instructions on handling the recalled tray.
The recall states the tray did not pass steam sterilization validation testing, so it may not be safe for surgical use.
Look for the product code 246111003 on the tray. All lots of this specific model are affected.
The recall does not specify a disposal or return action; 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-2363-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2363-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
