BEUDAMED
    FDA Recall Terminated

    ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-000.

    Recall: Z-1121-2008 · Initiated January 18, 2008

    Recall

    Recall Number
    Z-1121-2008
    Event Number
    46693
    FEI Number
    2183870
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    January 18, 2008
    Posted
    May 6, 2008
    Terminated
    November 4, 2008
    Address
    Ev3 Inc 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-000.

    Reason

    Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.

    Action

    ev3 notified all consignees via "Medical Device Recall" letter on 1/18/08. The letter was addressed to the Hospital and it described the device affected and the problem. The letter provided recommendations to segregate the affected devices and requested the return of the "Device Recall Field Action Reconciliation Form."

    Distribution

    Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.

    Quantity

    23