BEUDAMED
    FDA Enforcement Class II Terminated

    SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.

    Recall: Z-0923-2014 · Reported February 12, 2014

    Enforcement

    Recall Number
    Z-0923-2014
    Event ID
    67378
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Highland Metals, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2014
    Initiation Date
    December 13, 2013
    Classification Date
    February 3, 2014
    Termination Date
    February 4, 2014
    Address
    419 Perrymont Ave, San Jose, CA, 95125-1445, United States

    Description

    SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.

    Reason

    Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.

    Code Info

    Part Number Part Description Lot Number Label Form Actual Form 11100141124 SE Niti 014 Nat U 100 41756 Upper Lower 11100141144 SE Niti 014 Nat L 100 41760 Lower Upper 11100141145 SE Niti 014 Nat L 10 41760 Lower Upper

    Distribution

    Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.

    Quantity

    37 packages