Recall Z-2153-2024— Howmedica Osteonics Corp.
Class II · Ongoing
Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2024-05-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910. Reason: 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..
- Recalling firm
- Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-23
- Firm location
- Mahwah, NJ, United States
Product description
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.