KliniTray surgical alignment system recalled for microbial contamination risk
Klinika Medical is recalling the KliniTray tissue resection margin examination board (Model 2001105-F) due to potential microbial contamination. The device was distributed nationwide in Massachusetts.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device with potential microbial contamination, which presents a risk of harm in a surgical setting. The source text does not report any illnesses or injuries to date, making this a theoretical hazard situation that warrants a score of 3 per the rubric.
Plain-English summary
Klinika Medical is recalling the KliniTray surgical alignment system, specifically the tissue resection margin examination board/small (Model Number 2001105-F). The device is used to monitor, record, and visualize alignment during surgical procedures to ensure precise tissue orientation and positioning.
The recall is being issued due to potential for microbial contamination affecting 620 units. The recalled lot number is 25.019.01.
The device was distributed nationwide in the state of Massachusetts. Healthcare facilities and surgical centers that received this model should cease use and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Klinika Mdical Gmb
- Hazard
- Affected units
- 620
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 2001105-F. UDI-DI: 4053185001177. Lot Number: 25.019.01
Distribution
Part of a larger recall action
This product is one of 2 recalled by Klinika Mdical Gmb under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Klinika Mdical Gmb
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