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U.S. Department of Health and Human Services

Class 2 Device Recall TruDi Navigation System

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 Class 2 Device Recall TruDi Navigation Systemsee related information
Date Initiated by FirmOctober 03, 2025
Date PostedNovember 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0420-2026
Recall Event ID 97677
510(K)NumberK231862 
Product Classification Ear, Nose, and Throat Stereotaxic Instrument - Product Code PGW
ProductTruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Code Information Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp. (NeuroSciences)
1100 Campus Rd
Princeton NJ 08540-6650
For Additional Information ContactMary O'Neill
1-640-8679411
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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.
Quantity in Commerce1198 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PGW
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