BEUDAMED
    FDA Recall Terminated

    LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X REF: EL-200-4 and 10 X REF: EL-200-4, Manufactured by LiNA Medical ApS, Surgery Division.

    Recall: Z-2688-2011 · Initiated December 1, 2009

    Recall

    Recall Number
    Z-2688-2011
    Event Number
    58444
    Firm
    LINA Medical ApS Formervangen 5 Glostrup Denmark
    FEI Number
    3002626775
    Product Code
    KNF
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    December 1, 2009
    Posted
    June 28, 2011
    Terminated
    February 23, 2012

    Description

    LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X REF: EL-200-4 and 10 X REF: EL-200-4, Manufactured by LiNA Medical ApS, Surgery Division.

    Reason

    Potential for the LiNA Loop to break during operating procedure.

    Action

    Lina Medical Aps notified customers by newsletter in December 2009 followed by a letter to distributors including warnings added to instructions for use in January 2010.

    Distribution

    GA, MN, PA, WA, TN, MA, IN, Ontario Canada

    Quantity

    200 pieces