BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0826-2020 · Reported January 29, 2020

    Enforcement

    Recall Number
    Z-0826-2020
    Event ID
    84398
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Acclarent, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 29, 2020
    Initiation Date
    March 6, 2019
    Classification Date
    January 18, 2020
    Address
    33 Technology Dr, Irvine, CA, 92618-2346, United States

    Description

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

    Reason

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

    Code Info

    Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.

    Distribution

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