FDA Medical Device Recalls (openFDA)
Klinika Mdical Gmb: 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.
- Recall number
- Z-1768-2025
- Recalling firm
- Klinika Mdical Gmb
- 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 positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
- Status
- Open, Classified
- Initiated
- 2025-04-04
- Posted
- 2025-05-15
- Terminated
- not on file
- Reason
- Potential for microbial contamination.
- Root cause
- Process control
- Action
- Single distributor was notified via email on 04/04/2025 with an "URGENT FIELD SAFETY NOTICE - PRODUCT RECALL" letter. The letter instructed the distributor to Identify and quarantine all units of the affected LOT numbers, do not distribute or use these products, treat the products as non-sterile (clean packed) and ensure they are not used on the sterile field, and inform all relevant departments or customers within your distribution chain about this FSCA. Additionally, the distributor was requested to complete and return the acknowledgment form by 04/16/2025, even if you no longer have affected stock.
- Quantity
- 620 units
- Distribution
- US Nationwide distribution in the state of Massachusetts.
- Lot, serial or model codes
- Model Number: 2001105-F. UDI-DI: 4053185001177. Lot Number: 25.019.01
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMH
- Firm FEI
- 3008352701
- Firm city
- Usingen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28