# FDA recall Z-0826-2020

> **Acclarent, Inc.** · Class II · device recall initiated 2019-03-06.

## Product

TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891

## Reason for recall

The firm became aware that three (3) lots of the NAV Suction Instruments  contain calibration issues causing incorrect tip orientation display in the system.

## Distribution

US: WI, IL, NE, CA, OH, NY  OUS: None

## Key facts

- **Recall number:** Z-0826-2020
- **Recalling firm:** Acclarent, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-06
- **Report date:** 2020-01-29

- **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-0826-2020

## Citation

> AI Analytics. FDA recall Z-0826-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0826-2020. Source: US FDA. Licensed CC0.

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