Howmedica Osteonics recalls HRIS Storage & Sterilization Case P/N 6210-9-900 due to risk of reusing single-use sterile instruments. Affected units sold from 2006 onward.
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
Howmedica Osteonics is recalling HRIS Storage & Sterilization Cases and Trays with part number 6210-9-900 because they can lead to reusing single-use sterile instruments. This could cause infections or other health risks if instruments are reused improperly.
The case design may allow improper handling of Gray Revision Instruments, leading to re-use and re-sterilization of single-use instruments. This creates a risk of contamination and infection if instruments are not properly sterilized.
Healthcare professionals using these cases for surgical instruments are most at risk. Patients receiving procedures with reused instruments could face infections.
Check for part number 6210-9-900 on the HRIS Storage & Sterilization Case or Tray. Units were sold from 2006 onward with all lots.
Ensure instruments are not reused or re-sterilized after the case is used.
The design of the HRIS Storage & Sterilization Case and Tray may lead to reusing single-use sterile instruments, which can cause infections.
Part number 6210-9-900 for the HRIS Storage & Sterilization Case and Tray.
Units were sold from 2006 onward with all lots.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-2152-2024 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-2152-2024 from Howmedica Osteonics. 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.
