—#216327

Product

TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;

FDA product code: PGW — Ear, Nose, And Throat Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K231862
Affected lot / code info: Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;

Why it was 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.

Root cause (FDA determination)

Device Design

Action the firm took

On October 3, 2025 URGENT: VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. Actions to be Taken by Customers 1. Examine the your system to determine if you have product on hand subject to this field recall (Rev 00 and Rev01). 2. If you have revision 00 and/or revision 01, please check the box on the enclosed Acknowledgement Form I do have affected product(s) and record the total quantity of the affected product that you have. 3. If you do not have affected product, check the box, I do not have affected product. 4. Complete the rest of the Acknowledgement Form and return. 5. Keep a copy of the form for your records. 6. Forward this notice to those who utilize the product so they are aware of this recall and can identify and quarantine any affected product that may remain in clinical areas. 7. When your form is received, and it is noted that you have Rev 00 or Rev 01 products, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. You can request a replacement which you will receive depending on availability. 8. In an effort to prioritize replacement Adapters please note below (in the Medical Facilities Acknowledgement Form) if you have Rev 02 and Rev 03 to use for your upcoming planned surgeries.

Recalling firm

Firm: Integra LifeSciences Corp. (NeuroSciences)
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2025-10-03
Posted by FDA: 2025-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216327. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.