United StatesTruDi Navigation System — Multi Instrument Adapter, identified by Manufacturer’s Product Number (Catalog Number) EM-2025-000F Rev 00 or Rev 01 and UDI‑DI 10846835021103, is affected. It was recalled because when the system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker it may not meet its specified accuracy for visual verification of device location within the patient’s anatomy.
What's being recalled
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Recalling firm: Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States.
How to identify it
Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)