Integra recalls specific lots of TruDi NAV Suction instruments (TDNS000Z) for potential calibration errors that could cause surgical location mismatches when used with the TruDi Navigation System.
Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.
Integra is recalling specific lots of TruDi NAV Suction instruments (model TDNS000Z) because they may not calibrate correctly with the TruDi Navigation System during surgery. This could lead to inaccurate tip positioning in ENT or skull base procedures.
The instruments may show a different tip location than the actual position when used with the navigation system. This discrepancy could cause surgical errors during procedures where precise positioning is critical, such as in ENT or skull base surgery.
Surgical teams using the TruDi NAV Suction instruments with the TruDi Navigation System for ENT or skull base procedures. Patients undergoing these surgeries are at risk if the instruments are used with incorrect calibration.
Check for model number TDNS000Z and lot codes: 2310160, 2309110, 2309150, 2308140, 2308160, or 2308180. These instruments were sold with the TruDi Navigation System for ENT and skull base surgery procedures.
Identify the lot code on the instrument packaging or label to determine if it matches the recalled lots: 2310160, 2309110, 2309150, 2308140, 2308160, or 2308180.
The recalled model is TDNS000Z.
Lot codes 2310160, 2309110, 2309150, 2308140, 2308160, and 2308180 are affected.
Incorrect calibration could cause the surgical tip to appear in a different location than its actual position during procedures, potentially leading to surgical errors in ENT or skull base surgery.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-2507-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-2507-2024 from Integra. 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.
