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Integra LifeSciences Corp. (NeuroSciences) recalls TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev
Recalled November 12, 2025 · FDA recall Z-0420-2026 · 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. · FDA Class II
Units
1198 units
Sold at
US Nationwide distribution.
Description
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.
Product
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Manufacturer(s)
Integra LifeSciences Corp. (NeuroSciences)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →