BEUDAMED
    FDA Enforcement Class II Terminated

    Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis.

    Recall: Z-2690-2014 · Reported October 1, 2014

    Enforcement

    Recall Number
    Z-2690-2014
    Event ID
    69140
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Justright Surgical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 1, 2014
    Initiation Date
    August 27, 2014
    Classification Date
    September 23, 2014
    Termination Date
    October 6, 2014
    Address
    6325 Gunpark Dr, Suite G, Boulder, CO, 80301-3592, United States

    Description

    Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis.

    Reason

    JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.

    Code Info

    Lot: 75DD0406

    Distribution

    Distributed in the states of Colorado, California and New York.

    Quantity

    3 cases containing 18 units