BEUDAMED
    FDA Enforcement Class II Terminated

    Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

    Recall: Z-1491-2019 · Reported June 5, 2019

    Enforcement

    Recall Number
    Z-1491-2019
    Event ID
    82716
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    K2M, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2019
    Initiation Date
    April 18, 2019
    Classification Date
    May 25, 2019
    Termination Date
    June 19, 2020
    Address
    600 Hope Pkwy SE, N/A, Leesburg, VA, 20175-4428, United States

    Description

    Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

    Reason

    The products are mislabeled.

    Code Info

    All lots in distribution

    Distribution

    The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.

    Quantity

    462 total