TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Nu...
FDA Recall #Z-0420-2026 — Class II — October 3, 2025
Product Description
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Reason for Recall
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.
Recalling Firm
Integra LifeSciences Corp. (NeuroSciences) — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1198 units
Distribution
US Nationwide distribution.
Code Information
Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated