Navigation adapters recalled because the system may miss its specified accuracy
Integra LifeSciences is recalling 1,198 TruDi Navigation System Multi Instrument Adapters because certain revision combinations may not meet specified accuracy for locating a device in the anatomy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: a navigation system that misses its specified accuracy can misrepresent instrument position, and no injuries are reported.
Plain-English summary
The TruDi Navigation System Multi Instrument Adapter, catalog number EM-2025-000F Rev 00 or Rev 01, from Integra LifeSciences, is being recalled.
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 recall covers 1,198 units carrying UDI-DI 10846835021103, distributed nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record describes the accuracy shortfall and reports no injuries. Sites using an affected configuration should follow Integra's instructions.
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)
- Affected units
- 1,198
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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