FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp. (NeuroSciences): TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
- Recall number
- Z-0420-2026
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Product
- TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
- Status
- Open, Classified
- Initiated
- 2025-10-03
- Posted
- 2025-11-04
- Terminated
- not on file
- 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. 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
- 1198 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;
- 510(k) numbers
- ["K231862"]
- PMA numbers
- not on file
- Product code
- PGW
- Firm FEI
- 3003418325
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28