# FDA recall Z-2507-2024

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2024-07-09.

## Product

TruDi NAV Suction, 0 Degrees;  Model/Catalog Number: TDNS000Z.    TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery

## Reason for 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.

## 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.

## Key facts

- **Recall number:** Z-2507-2024
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-09
- **Report date:** 2024-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2507-2024

## Citation

> AI Analytics. FDA recall Z-2507-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2507-2024. Source: US FDA. Licensed CC0.

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