BEUDAMED
    FDA Enforcement Class II Terminated

    PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

    Recall: Z-2528-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2528-2020
    Event ID
    85830
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TeDan Surgical Innovations LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 15, 2020
    Initiation Date
    May 15, 2020
    Classification Date
    July 7, 2020
    Termination Date
    September 8, 2022
    Address
    12615 W Airport Blvd Ste 200, Sugar Land, TX, 77478-6203, United States

    Description

    PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

    Reason

    Lack of pouch seal. Product is labelled as sterile.

    Code Info

    Product Code: DS-0022 UDI Number: 00851797006474 Lot Number: 2018062901

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of: AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA . The countries of Australia, Canada, France, Philippines, Taiwan, U.A.E., and United Kingdom.

    Quantity

    730 screws (packaged into 146 boxes) - [5 screws per box]