BEUDAMED
    FDA Recall Terminated

    Stainless Steel, Progressive Lower, .016: Arch Wires. Intended for use in orthodontic treatment

    Recall: Z-2727-2011 · Initiated January 7, 2008

    Recall

    Recall Number
    Z-2727-2011
    Event Number
    59110
    Firm
    Highland Metals
    FEI Number
    1833132
    Product Code
    D
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 7, 2008
    Posted
    July 7, 2011
    Terminated
    July 7, 2011
    Address
    419 Perrymont Ave, San Jose, CA, 95125-1445

    Description

    Stainless Steel, Progressive Lower, .016: Arch Wires. Intended for use in orthodontic treatment

    Reason

    Boxes of stainless steel orthodontic wires were mislabeled as size.018"

    Action

    Highland Metals sent out "Highland Metals Advisory Notice Mislabeld Products Alert" and "Advisory Notice" letters from January 11, 2008 to April 18, 2008 to all affected costumers. The letter included: product name and affected lots. It advised them of the mislabeling and instructed them to return the product for replacement. For additional information contact Highland Metals at (408) 271-2955

    Distribution

    Worldwide distribution including the countries of Colombia, France, Scotland, Germany, Australia, Mexico, England, United Kingdom, Thailand; and (USA) Nationwide including the states of OK, CA, NJ, AZ, MD, LA, IL, PR, FL, NE, IN, TX, NH, NY, CO and PA.

    Quantity

    22 packs of 100