Gray Revision Instrument System Accessory Tray/Case recall
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Why was Gray Revision Instrument System Accessory Tray/Case 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part 6210-9-910, UDI-DI: 07613327217780, Lot#: All lots back to 2006.
- Product
- Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 209 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.
- Recall date
- June 26, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)