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.
This recall is currently active, issued May 15, 2025. It was issued by Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany.
- Recall Initiated
- April 4, 2025
- Posted
- May 15, 2025
- Recall Number
- Z-1769-2025
- Quantity
- 160 units
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for microbial contamination.
Distribution
US Nationwide distribution in the state of Massachusetts.
Lot / Code Info
Model Number: 2001155-F. UDI-DI: 4053185001177. Lot Number: 25.023.01
Root Cause
Process control
Action Taken
Single distributor was notified via email on 04/04/2025 with an "URGENT FIELD SAFETY NOTICE - PRODUCT RECALL" letter. The letter instructed the distributor to Identify and quarantine all units of the affected LOT numbers, do not distribute or use these products, treat the products as non-sterile (clean packed) and ensure they are not used on the sterile field, and inform all relevant departments or customers within your distribution chain about this FSCA. Additionally, the distributor was requested to complete and return the acknowledgment form by 04/16/2025, even if you no longer have affected stock.