BEUDAMED
    FDA Recall Terminated

    Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)

    Recall: Z-1875-2018 · Initiated March 20, 2018

    Recall

    Recall Number
    Z-1875-2018
    Event Number
    79824
    Firm
    Epic Extremity, LLC
    FEI Number
    3012453147
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    March 20, 2018
    Terminated
    April 25, 2019
    Address
    120 Marguerite Dr, Ste 301, Cranberry Twp, PA, 16066-5007

    Description

    Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)

    Reason

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

    Action

    Notification letters were sent on 3/20/18. The letters instructed customers to: We ask you to be aware of the incorrect numbers and ensure you are ordering the correct part numbers until replacement parts are available. You will be informed promptly of the availability of the replacement trays. You will be contacted to arrange return and to exchange the parts presently in your possession. Our records indicate that you have received one or more of the trays involved. Therefore, we would ask you to reply to this memo and confirm the quantities of each tray in your possession. Your response will serve as acknowledgement of this notification and that you will act in compliance. Please reply to [email protected]. The notification letter included photographs of products to indicate errors in labeling.

    Distribution

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

    Quantity

    9 units