BEUDAMED
    FDA Recall 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 · Initiated December 13, 2013

    Recall

    Recall Number
    Z-0923-2014
    Event Number
    67378
    Firm
    Highland Metals, Inc.
    FEI Number
    1833132
    Product Code
    DZC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 13, 2013
    Posted
    February 3, 2014
    Terminated
    February 4, 2014
    Address
    419 Perrymont Ave, San Jose, CA, 95125-1445

    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.

    Action

    Highland Metals sent an Urgent Field Safety Notice with a response form to all affected consignees on December 13, 2013, via email.. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to pass the Field Safety Notice to all those who needed to be aware within their organization or to any organization where the potentially affected devices have been transferred. Consignees were instructed to complete the Acknowledgement of Receipt and Action form and fax to 1-408-271-2962 or email to [email protected]. For questions regarding this recall call 408-271-2955.

    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