Integra LifeSciences Corp. (NeuroSciences): TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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;
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2025-10-03
- Code info
- Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; UDI-DI: 10846835021103;
- Product quantity
- 1198 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Princeton
- State
- NJ
- Country
- United States
- Event id
- 97677
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