BEUDAMED
    FDA Enforcement Class II Terminated

    Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7

    Recall: Z-0492-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0492-2014
    Event ID
    66536
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 25, 2013
    Initiation Date
    September 19, 2013
    Classification Date
    December 13, 2013
    Termination Date
    December 22, 2014
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7

    Reason

    The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.

    Code Info

    lots: 51468773, 51447588, 51468302, 51503760, 51571394, 51585136, 51447597

    Distribution

    Distributed in FL and MD.

    Quantity

    24