Z-2152-2024 Class II Ongoing
FDA device recall Z-2152-2024 was initiated by Howmedica Osteonics Corp. on May 23, 2024 and is designated Class II. 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 Instrume… The recall status is ongoing. Affected quantity: 630 units.
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
- 630 units
Product Description
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
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 6210-9-900, UDI-DI: 07613327217902, Lot#: All lots back to 2006.