Integra LifeSciences Corp. (NeuroSciences) recalls TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev…

Recall date

October 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0420-2026

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp. (NeuroSciences)

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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