BEUDAMED
    FDA Enforcement Class II Terminated

    Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)

    Recall: Z-0361-2014 · Reported November 27, 2013

    Enforcement

    Recall Number
    Z-0361-2014
    Event ID
    66534
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2013
    Initiation Date
    September 20, 2013
    Classification Date
    November 19, 2013
    Termination Date
    December 16, 2014
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)

    Reason

    The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel.

    Code Info

    model no. ME020R

    Distribution

    Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.

    Quantity

    30