TruDi Navigation System Adapter (Integra) – configuration risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Brand
Integra LifeSciences Corp. (NeuroSciences)
Lot Codes / Batch Numbers
Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01, UDI-DI: 10846835021103
Products Sold
Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;
Integra LifeSciences Corp. (NeuroSciences) is recalling TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number) due to It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026