Device product
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
Z-1769-2025
Product summary
- Event
- Event 96656
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 160 units
- Official record key
device-enforcement:Z-1769-2025
Official wording
Reason: Potential for microbial contamination.
Code information: Model Number: 2001155-F. UDI-DI: 4053185001177. Lot Number: 25.023.01
Distribution pattern: US Nationwide distribution in the state of Massachusetts.
Derived failure modes
-
Microbial contamination
microbial contamination