Z-0420-2026Class II

TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number)...

Name: Z-0420-2026 TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number)...
Creator: Integra LifeSciences Corp. (NeuroSciences)
Published: 2025-10-03
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2025-10-03 / Open, Classified / root cause: design

FDA source

Integra LifeSciences Corp. (NeuroSciences) began a recall of TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01 on 2025-10-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0420-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-03
Posted: 2025-11-04
Recalling firm: Integra LifeSciences Corporation
Product: TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Product code: PGW Ear, Nose, And Throat Stereotaxic Instrument
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.
Root cause tag: design
FDA 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. 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 commerce: 1198 units
Distribution: US Nationwide distribution.
Product codes and lots: Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0420-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0420-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-04

Product code PGW

K231862Class IITruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc. / cleared 2023-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)