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device recall
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Integra LifeSciences Corp. (NeuroSciences) device recall (Cls II)

October 3, 2025$IARTupdated 5mo ago
community read0 votes

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. — Status: Ongoing

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same company · ±60 days · 6

  • device 510kIntegra LifeSciences Corporation — CUSA® Clarity Ultrasonic Surgical Aspirator System (510k cleared)Oct 8, 2025
  • device recallIntegra LifeSciences Corp. (NeuroSciences) device recall (Cls I)Sep 26, 2025
  • device recallIntegra LifeSciences Corp. (NeuroSciences) device recall (Cls I)Sep 26, 2025
  • device pmaIntegra Lifesciences Corp. — INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Regen (PMA supplement)Sep 9, 2025
  • device recallIntegra LifeSciences Corp. (NeuroSciences) device recall (Cls II)Aug 5, 2025
  • device recallIntegra LifeSciences Corp. (NeuroSciences) device recall (Cls II)Aug 5, 2025

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