Device product
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Z-0420-2026
Product summary
- Event
- Event 97677
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1198 units
- Official record key
device-enforcement:Z-0420-2026
Official wording
Reason: It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
Code information: Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.