Lower risk Medical device recall · FDA · Published July 9, 2024

Integra TruDi NAV Suction 0 Degrees: Calibration Discrepancy Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2507-2024Medical device Integra ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmIntegra LifeSciences Corp.1100 Campus Rd · Princeton, NJ 08540-6650

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/54681-integra-trudi-nav-suction-0-degrees-calibration-discrepancy-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/54681-integra-trudi-nav-suction-0-degrees-calibration-discrepancy-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2507-2024

Cite this page

“Integra TruDi NAV Suction 0 Degrees: Calibration Discrepancy Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54681-integra-trudi-nav-suction-0-degrees-calibration-discrepancy-risk. Based on FDA recall #Z-2507-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2507-2024%22&limit=1).

Integra LifeSciences Corp. voluntarily recalled TruDi NAV Suction Instruments on July 9, 2024, according to FDA records (Z-2507-2024). Specific lots were incorrectly calibrated, potentially causing a discrepancy between the actual tip location and the visualized location when used with the TruDi Navigation System.

How to tell if you have it

Brand: Integra
Product: TruDi NAV Suction Instruments, 0 Degrees
Model/Catalog Number: TDNS000Z
Lot Codes: 2310160, 2309110, 2309150, 2308140, 2308160, 2308180
Units affected: 265

The hazard

The FDA reported that specific lots of the TruDi NAV Suction Instruments were incorrectly calibrated. When used with the TruDi Navigation System, this may result in a discrepancy between the actual tip location and the visualized location displayed on the system.

Context

GovInfoNow's records show Integra LifeSciences Corp. has issued 35 other recalls since August 18, 2017. Recent brand recalls include an AURORA Surgiscope System recall on February 6, 2025, for a risk of obturator breaking, and a MediHoney Wound Dressing Gel recall on January 10, 2025, for induction seal packaging risks. Other recent recalls of similar products include an Alphatec LIF NAV Osteotome 10mm recall on January 2, 2026, for incorrect navigation geometry risk and a Think Surgical TMINI Tracking Arrays recall on May 8, 2026, for risk of misalignment due to loose knob.

How to tell if you have this one

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.

Brand
Integra
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Instrument Lot Code
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.

Where it went and when

Where it was distributed

Distributed in 35 states.

FDA distribution: “The devices are only sold in the US. The following states have received the product: AL, AZ CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, PA, SC, SD, TN, TX, VA, VT, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Wisconsin.

Recall timeline

FDA published this recall 36 days after the firm started it.

Jul 9, 2024Firm started the recall
Aug 5, 2024FDA classified it Class II
Aug 14, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/54681-integra-trudi-nav-suction-0-degrees-calibration-discrepancy-risk">Integra TruDi NAV Suction 0 Degrees: Calibration Discrepancy Risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-2507-2024 (July 9, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2507-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.