Howmedica Osteonics recalls Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 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 a specific surgical instrument case and tray because improper use could lead to reusing single-use sterile instruments. This poses a risk of infection or injury if instruments are reused after sterilization.
The case and tray design may lead to reusing single-use, sterile-packaged surgical instruments. Reusing these instruments after sterilization can cause infections or injuries due to contamination.
Surgical staff and hospitals that use the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 are most at risk. Patients could be exposed to infection if instruments are reused.
Check for the part number 6210-9-910 on the Gray Revision Instrument System Accessory Tray/Case. Units were sold from 2006 onward with all lots.
Identify the part number 6210-9-910 on the Gray Revision Instrument System Accessory Tray/Case.
Reach out to Howmedica Osteonics for guidance on proper disposal or alternative solutions.
The part number is 6210-9-910 for the Gray Revision Instrument System Accessory Tray/Case.
These items were sold from 2006 onward with all lots.
Check for the part number 6210-9-910 on the Gray Revision Instrument System Accessory Tray/Case.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-2153-2024 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-2153-2024 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.
