BEUDAMED
    FDA Enforcement Class II Terminated

    JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and creation of anastomosis.

    Recall: Z-1956-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1956-2015
    Event ID
    71521
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Justright Surgical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2015
    Initiation Date
    June 11, 2015
    Classification Date
    July 2, 2015
    Termination Date
    August 26, 2015
    Address
    6325 Gunpark Dr, Suite G, Boulder, CO, 80301-3592, United States

    Description

    JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and creation of anastomosis.

    Reason

    JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue closure.

    Code Info

    Model Number JR-REL25-2.0 Lot numbers 75ED0114, 75JD1403, 75KD0304, 75KD0726, 75LD1224, 75AE0707, 75AE1406, 75BE1310, 75BE1313, 75CE2605, 75DE0802, and 75DE1524.

    Distribution

    Distribution - US Nationwide and Ireland.

    Quantity

    1452