Oct

2023

FDA Recall: Discrepancy between location of curette tip during surgery

Company: Acclarent, Inc.
Date of Enforcement Report: 10/20/2023
Class II

PRODUCT

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

Recall Number:

Z-0127-2024

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Acclarent, Inc.

VOLUME OF PRODUCT IN COMMERCE:

141

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

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Discrepancy between location of curette tip during surgery

Allison Pate

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