Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TruDi¿ Navigation System - Multi Instrument Adapter Recalled by Integra LifeSciences Corp. (NeuroSciences) Due to It was determined that when the navigation system...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. (NeuroSciences) directly.
Affected Products
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Quantity: 1198 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Integra LifeSciences Corp. (NeuroSciences)
Integra LifeSciences Corp. (NeuroSciences) has 23 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report