BEUDAMED
    FDA Enforcement Class II Terminated

    Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).

    Recall: Z-2092-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2092-2014
    Event ID
    68667
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alphatec Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2014
    Initiation Date
    June 26, 2014
    Classification Date
    July 22, 2014
    Termination Date
    September 3, 2014
    Address
    5818 El Camino Real, Carlsbad, CA, 92008-8816, United States

    Description

    Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).

    Reason

    Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use.

    Code Info

    Lot No. 7117902

    Distribution

    Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.

    Quantity

    14 units total (12 units in US)