HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Reported: June 26, 2024 Initiated: May 23, 2024 #Z-2152-2024
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.
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 630 units
- Distribution
- 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.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900. Recalled by Howmedica Osteonics Corp.. Units affected: 630 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 26, 2024. Severity: Moderate. Recall number: Z-2152-2024.
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