BEUDAMED
    FDA Enforcement Class II Terminated

    Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.

    Recall: Z-0821-2016 · Reported February 24, 2016

    Enforcement

    Recall Number
    Z-0821-2016
    Event ID
    72749
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 24, 2016
    Initiation Date
    December 2, 2015
    Classification Date
    February 18, 2016
    Termination Date
    July 18, 2019
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908, United States

    Description

    Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.

    Reason

    Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use

    Code Info

    Lot numbers within each range are affected: Lot # starting with P3C through P5B0454X, P5B0468X, P5C0152X through P5E0450X. Individual Lot Number: P5B0468X, P5E0523X, P5E0273X

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.

    Quantity

    327,797 units