[pending] TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Numbe
Pending LLM rewrite. Source: FDA_DEVICE Z-0420-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01
- UDI-DI: 10846835021103
Distribution
Distributed nationwide across the United States.
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