Biomet recalls all lots of Orthopedic Manual Surgical Instruments with Outer Sheaths 4.5/5.0,6.5 due to potential failure in steam sterilization validation testing.
Device and tray that houses the device did not pass steam sterilization process validation testing
Biomet is recalling all lots of their Orthopedic Manual Surgical Instruments with Outer Sheaths 4.5/5.0,6.5. This recall is because the sheaths did not pass steam sterilization validation testing, which could lead to improper sterilization and potential infection risks.
The sheaths failed steam sterilization validation testing, meaning they may not be properly sterilized. This could lead to the instruments being contaminated and potentially causing infections during surgical procedures.
Healthcare professionals and surgical teams using Biomet's Orthopedic Manual Surgical Instruments with Outer Sheaths 4.5/5.0,6.5 are affected. The risk is highest for those handling the instruments in clinical settings.
Check for the product name 'Biomet Outer Sheath 4.5/5.0,6.5' and product code 14235. All lots of this instrument are affected.
Verify the product code 14235 and model number for the Orthopedic Manual Surgical Instrument with Outer Sheaths 4.5/5.0,6.5.
The recall indicates the sheaths did not pass steam sterilization validation testing, so they may not be properly sterilized. Use only the recalled product if it has been validated by Biomet.
Check for the product code 14235 and model number 'Biomet Outer Sheath 4.5/5.0,6.5' on the instrument packaging or label.
The recall does not specify a remedy, so contact Biomet directly for guidance on handling the product.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2362-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2362-2020 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.
