FDA-Device2025-11-12Class II
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Integra LifeSciences Corp. (NeuroSciences)
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
1198 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0420-2026Don't want to check this manually?
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