BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0082-2013 · Initiated May 9, 2012

    Recall

    Recall Number
    Z-0082-2013
    Event Number
    63223
    Firm
    Aesculap, Inc.
    FEI Number
    2916714
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    May 9, 2012
    Posted
    October 18, 2012
    Terminated
    January 15, 2014
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    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.

    Action

    Both consignees were notified verbally on May 15, 2012 and asked to inspect their inventory for the recalled items, remove the mislabeled instruments and return them to the recalling firm. Both mislabeled instruments were returned to the firm. Customer questions were directed to (610) 984-9074.

    Distribution

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

    Quantity

    2