Integra LifeSciences recalls TruDi Navigation System Multi Instrument Adapters (EM-2025-000F Rev 00/01) due to potential accuracy problems during patient anatomy verification. Affected users should contact for details.
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.
Integra LifeSciences is recalling its TruDi Navigation System Multi Instrument Adapters (model EM-2025-000F Rev 00 or 01) because they may not work accurately when used with certain patient trackers. This could lead to incorrect visual verification of device location in patients.
The Multi Instrument Adapter may not meet the required accuracy levels when paired with specific patient trackers. This could cause incorrect visual verification of the device's position within a patient's anatomy during medical procedures.
Medical professionals using the TruDi Navigation System with specific patient trackers are most at risk. The recall affects devices sold with the manufacturer's product number EM-2025-000F Rev 00 or 01.
Check for the manufacturer's product number EM-2025-000F Rev 00 or Rev 01 on the adapter. The recall applies to devices sold with this specific model number.
Verify the model number on the adapter to confirm if it is EM-2025-000F Rev 00 or Rev 01.
The recall is due to potential accuracy issues when the Multi Instrument Adapter is used with specific patient trackers, which could affect visual verification of device location in patients.
Check the model number on the adapter. If it matches EM-2025-000F Rev 00 or 01, contact Integra LifeSciences for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0420-2026 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0420-2026 from Integra LifeSciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
