Howmedica Osteonics Corp.: Device Recall
Recall #Z-2152-2024 · 05/23/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2152-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Howmedica Osteonics Corp.
- Status
- Ongoing
- Date Initiated
- 05/23/2024
- Location
- Mahwah, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 630 units
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.
Product Description
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Distribution Pattern
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.
Other Recalls by Howmedica Osteonics Corp.
- Class II: Risk 11/12/2025
- Class II: Risk 08/28/2025
- Class II: Risk 09/04/2024
- Class II: Risk 08/07/2024
- Class II: Risk 08/05/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.