BEUDAMED
    FDA Enforcement Class II Terminated

    Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    Recall: Z-1785-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1785-2018
    Event ID
    79739
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TP Orthodontics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    May 16, 2018
    Initiation Date
    May 1, 2018
    Classification Date
    May 10, 2018
    Termination Date
    April 15, 2020
    Address
    100 Center Plz, N/A, La Porte, IN, 46350-9672, United States

    Description

    Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    Reason

    The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.

    Code Info

    16015000, 17315000, 17715000, 18115000, 19515000, 24015000, 26515000, 30015000, 32315000, 32815000, 33515000

    Distribution

    Distributed to accounts in 20 states: AL, CA, CO, FL, HI, ID, IL, MA, ME, MI, NJ, NV, NY, OH, OR, PA, SC, TX, UT, and VA. Foreign distribution to United Arab Emirates, Australia, Belgium, Brazil, Canada, Germany, Spain, Finland, France, Great Britain, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Portugal, Singapore, and South Africa.

    Quantity

    126