BEUDAMED
    FDA Enforcement Class II Terminated

    OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

    Recall: Z-0026-2013 · Reported October 17, 2012

    Enforcement

    Recall Number
    Z-0026-2013
    Event ID
    54725
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthohelix Surgical Designs Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 17, 2012
    Initiation Date
    January 29, 2010
    Classification Date
    October 9, 2012
    Termination Date
    February 20, 2013
    Address
    1065 Medina Rd., Suite 500, N/A, Medina, OH, 44256, United States

    Description

    OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

    Reason

    The tips of the drivers are breaking while being used to drive the screws into patients.

    Code Info

    HSC-056-32-1067051

    Distribution

    Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI.

    Quantity

    47 Pieces