BEUDAMED
    FDA Enforcement Class II Terminated

    Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

    Recall: Z-0908-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0908-2018
    Event ID
    79166
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 14, 2018
    Initiation Date
    September 15, 2017
    Classification Date
    March 5, 2018
    Termination Date
    December 19, 2018
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

    Reason

    The device cartridge disengaged during use due to manufacturing error.

    Code Info

    Product number: EGIARADXT Lot code: N6L0351X

    Distribution

    Internationally, including Japan. No USA Customers

    Quantity

    163