BEUDAMED
    FDA Enforcement Class II Terminated

    CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.

    Recall: Z-0720-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0720-2020
    Event ID
    84295
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2020
    Initiation Date
    November 11, 2019
    Classification Date
    December 20, 2019
    Termination Date
    April 1, 2021
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209, United States

    Description

    CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.

    Reason

    A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.

    Code Info

    UDI (01) 05415067028693(17)220131(10) 6865795 lot 6865795

    Distribution

    Worldwide distribution - US Nationwide and country of Bermuda.

    Quantity

    470 devices