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Howmedica Osteonics Corp. recalls Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Recalled June 26, 2024 · FDA recall Z-2153-2024 · Howmedica Osteonics
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. · FDA Class II
Units
209 units
Sold at
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.
Description
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.
Product
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Manufacturer(s)
Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →