BEUDAMED
    FDA Recall 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 · Initiated June 13, 2019

    Recall

    Recall Number
    Z-1973-2019
    Event Number
    83166
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    OVE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 13, 2019
    Terminated
    May 11, 2020
    Address
    350 Main St, Malden, MA, 02148-5089

    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.

    Action

    Urgent Medical Device Recall letters dated 6/13/19 were emailed to customers.

    Distribution

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

    Quantity

    6