FDAOctober 3, 2025device
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Ongoing
Brands named
integra lifesciences corp neurosciencesintegraintegra lifesciences
UPCs
10846835021103
Recall history
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