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U.S. Department of Health and Human Services

Class 2 Device Recall KliniTray

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 Class 2 Device Recall KliniTraysee related information
Date Initiated by FirmApril 04, 2025
Date PostedMay 15, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1769-2025
Recall Event ID 96656
Product Classification Container, specimen, sterile - Product Code FMH
ProductKliniTray 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.
Code Information Model Number: 2001155-F. UDI-DI: 4053185001177. Lot Number: 25.023.01
Recalling Firm/
Manufacturer		 Klinika Mdical Gmb
Achtzehnmorgenweg 6
Usingen Germany
Manufacturer Reason
for Recall		Potential for microbial contamination.
FDA Determined
Cause 2		Process control
ActionSingle 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.
Quantity in Commerce160 units
DistributionUS Nationwide distribution in the state of Massachusetts.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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