FDAFDA · Food and drugs·Recall number Z-2153-2024
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Published June 26, 2024 · Recall initiated: May 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Howmedica Osteonics Corp.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, UK, Venlo.
- Lot
- Part 6210-9-910, UDI-DI: 07613327217780, Lot#: All lots back to 2006.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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