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

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.

Details from the source

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. Quantity: 1198 units Lot/code info: Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;

UPC codes

10846835021103

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.