Z-0420-2026 Class II Ongoing
FDA device recall Z-0420-2026 was initiated by Integra LifeSciences Corp. (NeuroSciences) on October 3, 2025 and is designated Class II. 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 specif… The recall status is ongoing. Affected quantity: 1198 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 12, 2025
- Initiation Date
- October 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1198 units
Product Description
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
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 Pattern
US Nationwide distribution.
Code Information
Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;