Recall Z-0420-2026— Integra LifeSciences Corp. (NeuroSciences)
Class II · Ongoing
Class II FDA medical device recall by Integra LifeSciences Corp. (NeuroSciences), initiated 2025-10-03. It names one FDA 510(k) clearance: K231862. Product: TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;. 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..
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-03
- Firm location
- Princeton, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.