BEUDAMED
    FDA Recall 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 · Initiated June 11, 2015

    Recall

    Recall Number
    Z-1956-2015
    Event Number
    71521
    Firm
    Justright Surgical, LLC
    FEI Number
    3010377594
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 11, 2015
    Posted
    July 2, 2015
    Terminated
    August 26, 2015
    Address
    6325 Gunpark Dr, Suite G, Boulder, CO, 80301-3592

    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.

    Action

    JustRight Surgical sent an Urgent Medical Device Recall letter dated June 12, 2015 to aaffected customers and distributor via an email. The letter identified the affected product, problem and actions to be taken. Custers were instructed Review, complete, and return the enclosed Acknowledgement Form directly to Rep, your Sales Representative or email to [email protected] or fax to (720) 287-7135. The following assistance is available: " For questions related to the issue or product replacement, please contact your local sales representative, Rep, or contact JustRight Surgical Customer Service at (866) 683-1743, Monday through Friday from 7:30 AM to 5:00 PM MST. " For questions related to product pick-up by JustRight Surgical, please also contact your local sales representative or Customer Service (866) 683-1743. Return instructions are provided on the Acknowledgement Form. " For questions related to the Acknowledgement Form and its return, please contact the JustRight Surgical Director of Quality Systems at (720) 287-7146.

    Distribution

    Distribution - US Nationwide and Ireland.

    Quantity

    1452