BEUDAMED
    FDA Recall 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 · Initiated July 15, 2013

    Recall

    Recall Number
    Z-2264-2013
    Event Number
    66063
    Firm
    Endoplus, Inc.
    FEI Number
    3000719482
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 15, 2013
    Posted
    September 21, 2013
    Terminated
    February 8, 2016
    Address
    750 Tower Rd, Suite A, Mundelein, IL, 60060-3818

    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.

    Action

    Letters were sent on 7/15/2013 to all customers notifying them of the recall. The letters requested that customers return the recalled devices via private courier using an enclosed account number. Replacement devices will be made available upon customer request.

    Distribution

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

    Quantity

    81 units