BEUDAMED
    FDA Enforcement Class II Terminated

    Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)

    Recall: Z-1874-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1874-2018
    Event ID
    79824
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Epic Extremity, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 23, 2018
    Initiation Date
    March 20, 2018
    Classification Date
    May 15, 2018
    Termination Date
    April 25, 2019
    Address
    120 Marguerite Dr Ste 301, Cranberry Twp, PA, 16066-5007, United States

    Description

    Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)

    Reason

    There is an error in the caddy artwork that misidentifies a specific plate and screw.

    Code Info

    Catalog Number: 2111-0005 Lot: 51464

    Distribution

    The products were distributed to the following US states: FL, PA, and VA.

    Quantity

    6 units