BEUDAMED
    FDA Enforcement Class II Terminated

    Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)

    Recall: Z-0082-2013 · Reported October 24, 2012

    Enforcement

    Recall Number
    Z-0082-2013
    Event ID
    63223
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 24, 2012
    Initiation Date
    May 9, 2012
    Classification Date
    October 18, 2012
    Termination Date
    January 15, 2014
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)

    Reason

    The manufacturer informed the recalling firm of a potential laser marking error in size identification on two Columbus 4-IN-1 Femoral Cutting Guide Instruments. The guides are correctly dimensioned, but the laser markings have been incorrectly etched.

    Code Info

    NQ083R

    Distribution

    Within the US, product was distributed to PA and TN.

    Quantity

    2