KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device Kl
Summary
The FDA issued a Class II for KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Nu by Klinika Mdical Gmb. Reason: Potential for microbial contamination..
Details
Source
Device Recall
External ID
Z-1768-2025
Action Date
2025-05-21
Status
Ongoing
Category
device
Product Description
KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-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.
Lot/Code Info: Model Number: 2001105-F. UDI-DI: 4053185001177. Lot Number: 25.019.01
Quantity Affected: 620 units
Reason for Recall
Potential for microbial contamination.
Distribution
US Nationwide distribution in the state of Massachusetts.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-04
Company
Usingen
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Klinika Mdical Gmb has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Klinika Mdical Gmb) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Klinika Mdical Gmb have FDA actions?
Klinika Mdical Gmb has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1768-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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