FDA recall Z-1769-2025

Klinika Mdical Gmb · Class II · 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.

Reason for recall

Potential for microbial contamination.

Distribution

US Nationwide distribution in the state of Massachusetts.

Key facts

Status
Ongoing
Initiation date
2025-04-04
Report date
2025-05-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Usingen, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1769-2025