BEUDAMED
    FDA Recall 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 · Initiated August 27, 2014

    Recall

    Recall Number
    Z-2690-2014
    Event Number
    69140
    Firm
    Justright Surgical, LLC
    FEI Number
    3010377594
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 27, 2014
    Posted
    September 23, 2014
    Terminated
    October 6, 2014
    Address
    6325 Gunpark Dr, Suite G, Boulder, CO, 80301-3592

    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.

    Action

    Consignees were notified via letter on August 27, 2014 in addition, the sales rep will hand deliver the Recall Notification on 8/28/14. Acknowledgement Form will be provided and returned products will be sent to STD Med where it will be held in quarantine.

    Distribution

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

    Quantity

    3 cases containing 18 units