BEUDAMED
    FDA Recall Terminated

    Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

    Recall: Z-0900-2017 · Initiated October 25, 2016

    Recall

    Recall Number
    Z-0900-2017
    Event Number
    75740
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    KWT
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 25, 2016
    Terminated
    July 26, 2019
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

    Reason

    Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.

    Action

    Exactech sent an Advisory Notice on October 25, 2016, to Exactech field agents in the U.S. Agents outside of the U.S. were notified on November 2, 2016. Field agents were notified of the recall in the Advisory Notice and asked to notify their accounts that may have the recalled product in stock. Agents were required to complete and return the Field Advisory Notice Response Form within 5 working days. For further questions, please call (352) 377-1140.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MD, ME, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TN, VA, WA and WI., and to the countries of : Austria, Australia, Canada, Germany, France, Spain, India, Switzerland, Italy, South Korea, United Kingdom, Brazil, Luxembourg, Greece, Guatemala, Netherlands, South Africa, and Sweden

    Quantity

    2,278 units