Recall Z-1769-2025— Klinika Mdical Gmb
Class II · Ongoing
Class II FDA medical device recall by Klinika Mdical Gmb, initiated 2025-04-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Potential for microbial contamination..
- Recalling firm
- Klinika Mdical Gmb
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-04
- Firm location
- Usingen, Germany
Product description
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.
Reason for recall
Potential for microbial contamination.
Data sourced from openFDA. This site is unofficial and independent of the FDA.