Recall Z-0420-2026 · PGW Ear, Nose, And Throat Stereotaxic Instrument
Integra LifeSciences Corp. (NeuroSciences)
TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
| Date | Nov 4, 2025 (initiated Oct 3, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 1198 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231862 | TruDi® Navigation System V3 (FG-2000-00) Acclarent, Inc., Jul 21, 2023 |