BEUDAMED
    FDA Enforcement Class II Terminated

    ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.

    Recall: Z-2264-2013 · Reported October 2, 2013

    Enforcement

    Recall Number
    Z-2264-2013
    Event ID
    66063
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Endoplus, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2013
    Initiation Date
    July 15, 2013
    Classification Date
    September 21, 2013
    Termination Date
    February 8, 2016
    Address
    750 Tower Rd, Suite A, Mundelein, IL, 60060-3818, United States

    Description

    ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.

    Reason

    Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.

    Code Info

    Item: 346VA; Lot Numbers: D3, E3, F3

    Distribution

    Distributed in the states of FL, TX, and VA.

    Quantity

    81 units