FDA Recalls KliniTray Model 2001155-F Surgical Device for Microbial Contamination Risk
The FDA has recalled KliniTray tissue examination boards (Model 2001155-F) due to potential microbial contamination. These surgical devices are used to position and examine tissue samples during procedures.
What this means for you
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 high-risk surgical device with potential for microbial contamination. Although no illnesses or injuries have been reported, the risk of contamination in surgical procedures makes this a high-severity recall under the rubric criterion for risk-of-harm products without yet-reported injury.
Plain-English summary
Klinika Mdical Gmb is recalling KliniTray Platte Faxitron tissue resection margin examination boards (Model 2001155-F) due to potential for microbial contamination. The device is a sterile surgical instrument used for precise monitoring and positioning of tissue during surgical procedures.
Approximately 160 units with the affected lot number 25.023.01 have been distributed in the United States. The device's model number is 2001155-F, and its UDI-DI is 4053185001177.
Patients who have undergone surgical procedures with these devices should contact their healthcare provider with concerns. Healthcare facilities that received these devices should stop using them and contact Klinika Mdical Gmb for information about returns or replacements.
The recalled product
- Product
- 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
- Manufacturer
- Klinika Mdical Gmb
- Hazard
- microbial-contamination
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: 2001155-F. UDI-DI: 4053185001177. Lot Number: 25.023.01
Distribution
Distributed nationwide across the United States.
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