Z-2153-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2024
- Initiation Date
- May 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 209 units
Product Description
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Part 6210-9-910, UDI-DI: 07613327217780, Lot#: All lots back to 2006.