FDA Medical devices recall ·
KliniTray Platte Faxitron ,groB "R" sterile recall
- Recall number
- Z-1769-2025
- Date
- (initiated April 4, 2025)
- Company / brand
- Klinika Mdical Gmb
Achtzehnmorgenweg 6, Usingen, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 160 units
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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 orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
Why was it recalled?
Potential for microbial contamination.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 2001155-F. UDI-DI: 4053185001177. Lot Number: 25.023.01
Distribution
US Nationwide distribution in the state of Massachusetts.
States: Massachusetts
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1769-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.