# FDA recall Z-0127-2024

> **Acclarent, Inc.** · Class II · device recall initiated 2023-09-21.

## Product

TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005

## Reason for recall

When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.

## Distribution

US: CA, IL, WI, MA, TX, CO, FL, ID, KS, OH, OR, NE, MO, AZ, HI, TN, NY, ME, SC, NC, CT, DC, MN, LA, OK, PA, AL, IA, MI, SD

## Key facts

- **Recall number:** Z-0127-2024
- **Recalling firm:** Acclarent, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-21
- **Report date:** 2023-11-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0127-2024

## Citation

> AI Analytics. FDA recall Z-0127-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0127-2024. Source: US FDA. Licensed CC0.

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