# FDA recall Z-0420-2026

> **Integra LifeSciences Corp. (NeuroSciences)** · Class II · device recall initiated 2025-10-03.

## Product

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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0420-2026
- **Recalling firm:** Integra LifeSciences Corp. (NeuroSciences)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-03
- **Report date:** 2025-11-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0420-2026

## Citation

> AI Analytics. FDA recall Z-0420-2026. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-0420-2026. Source: US FDA. Licensed CC0.

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