Reported May 21, 2025 · Ongoing
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F…
Klinika Mdical Gmb
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Klinika Mdical Gmb · Achtzehnmorgenweg 6 · Usingen · N/A
Is this the product you have?
- KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin
- examination board/large Model Number2001155-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 codes and dates
- Model Number2001155-F
- UDI-DI4053185001177
- Lot Number25.023.01
- Amount recalled
- 160 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- MA
Why it was recalled
Potential for microbial contamination.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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