FDA recall Z-0826-2020

Acclarent, Inc. · Class II · device

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

Status: Terminated
Initiation date: 2019-03-06
Report date: 2020-01-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0826-2020