BEUDAMED
    FDA Recall Terminated

    Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe used in conjunction with the CompuDent STA computer controlled dental injection system.

    Recall: Z-1952-2015 · Initiated February 11, 2015

    Recall

    Recall Number
    Z-1952-2015
    Event Number
    70742
    Firm
    Milestone Scientific, Inc.
    FEI Number
    3004082685
    Product Code
    EJI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 11, 2015
    Posted
    July 1, 2015
    Terminated
    September 20, 2016
    Address
    220 S Orange Ave, Livingston, NJ, 07039-5804

    Description

    Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe used in conjunction with the CompuDent STA computer controlled dental injection system.

    Reason

    Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument.

    Action

    Milestone Scientific notified their customers via e-mail and phone on 2/11/2015.

    Distribution

    Worldwide distribution. US in FL, IL, NY WA and Puerto Rico, Israel, Croatia, Italy, Australia, Germany, Colombia, UK, Sweden, and UAE.

    Quantity

    165,850 units