Class II

Medical Device Recall: TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;

Integra LifeSciences Corp. (NeuroSciences) · October 3, 2025

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.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

1198 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0420-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.