Z-1768-2025 Class II Ongoing
FDA device recall Z-1768-2025 was initiated by Klinika Mdical Gmb on April 4, 2025 and is designated Class II. Reason for recall: Potential for microbial contamination. The recall status is ongoing. Affected quantity: 620 units.
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