Z-1768-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2025
- Initiation Date
- April 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 620 units
Product Description
KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-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.
Reason for Recall
Potential for microbial contamination.
Distribution Pattern
US Nationwide distribution in the state of Massachusetts.
Code Information
Model Number: 2001105-F. UDI-DI: 4053185001177. Lot Number: 25.019.01