FDA Enforcement
Class II
Ongoing
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Recall: Z-0420-2026
·
Reported November 12, 2025
Enforcement
- Recall Number
- Z-0420-2026
- Event ID
- 97677
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp. (NeuroSciences)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 12, 2025
- Initiation Date
- October 3, 2025
- Classification Date
- November 4, 2025
- Address
- 1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States
Description
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Reason
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.
Code Info
Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;
Distribution
US Nationwide distribution.
Quantity
1198 units