BEUDAMED
    FDA Enforcement Class II Terminated

    A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)

    Recall: Z-1973-2019 · Reported July 24, 2019

    Enforcement

    Recall Number
    Z-1973-2019
    Event ID
    83166
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2019
    Initiation Date
    June 13, 2019
    Classification Date
    July 12, 2019
    Termination Date
    May 11, 2020
    Address
    350 Main St, N/A, Malden, MA, 02148-5089, United States

    Description

    A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)

    Reason

    There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.

    Code Info

    Lot EC20

    Distribution

    The products were distributed to the following US states: AZ, MD, MO, and FL.

    Quantity

    6