BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0361-2014 · Initiated September 20, 2013

    Recall

    Recall Number
    Z-0361-2014
    Event Number
    66534
    Firm
    Aesculap, Inc.
    FEI Number
    2916714
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 20, 2013
    Posted
    November 19, 2013
    Terminated
    December 16, 2014
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    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.

    Action

    An Important Product Removal Notification dated September 20, 2013 was sent to customers.

    Distribution

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

    Quantity

    30