FDA-Device2024-06-26Class II
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Howmedica Osteonics Corp.
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.
Sold states
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.
Affected count
630 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2152-2024Don't want to check this manually?
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