BEUDAMED
    FDA Enforcement Class II Terminated

    40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.

    Recall: Z-1412-2013 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1412-2013
    Event ID
    64586
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spinal Solutions, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2013
    Initiation Date
    February 20, 2013
    Classification Date
    May 27, 2013
    Termination Date
    March 26, 2014
    Address
    26157 Jefferson Ave, N/A, Murrieta, CA, 92562-9561, United States

    Description

    40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.

    Reason

    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

    Code Info

    Item #BG1640

    Distribution

    USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.

    Quantity

    63 units