BEUDAMED
    FDA Recall Terminated

    Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6 packages of 10. Highland Metals, Inc. Wire used for orthodontic treatment to place in the brackets to shape teeth.

    Recall: Z-2963-2011 · Initiated July 12, 2011

    Recall

    Recall Number
    Z-2963-2011
    Event Number
    59349
    Firm
    Highland Metals
    FEI Number
    1833132
    Product Code
    D
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    July 12, 2011
    Posted
    August 9, 2011
    Terminated
    September 14, 2011
    Address
    419 Perrymont Ave, San Jose, CA, 95125-1445

    Description

    Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6 packages of 10. Highland Metals, Inc. Wire used for orthodontic treatment to place in the brackets to shape teeth.

    Reason

    Heat Activated Niti, Natural, Upper, .019 x 25" Arch wires mixed with size 021x0.25" Arch Wires.

    Action

    Highland Metals, Inc. notified their affected customers by e-mail and followed with an "Important Alert" letter dated July 12, 2011. The letters informed customers of the mix up of wires. Customers were asked to contact Highland Metals at 800-368-6484 to schedule a call tag to return any remaining product. Upon receipt credit will be issued. For additional information contact Highland Metals at (800) 448-7971 or (408) 271-2955.

    Distribution

    Worldwide Distribution; Nationwide (USA) distribution including the states of NV, CT, and FL; and the countries of Australia and Turkey.

    Quantity

    10 packages of 100