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.
Reported: May 21, 2025 Initiated: April 4, 2025 #Z-1769-2025
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.
Details
- Recalling Firm
- Klinika Mdical Gmb
- Units Affected
- 160 units
- Distribution
- US Nationwide distribution in the state of Massachusetts.
- Location
- Usingen
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Klinika Mdical Gmb. Units affected: 160 units.
Why was this product recalled? ▼
Potential for microbial contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 21, 2025. Severity: Moderate. Recall number: Z-1769-2025.
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