BEUDAMED
    FDA Enforcement Class II Ongoing

    Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT

    Recall: Z-2507-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2507-2018
    Event ID
    80423
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    COVIDIEN MEDTRONIC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    May 22, 2018
    Classification Date
    July 19, 2018
    Address
    60 NIDDLETOWN AVE 2ND F, NORTH HAVEN, CT, 06473, United States

    Description

    Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT

    Reason

    Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

    Code Info

    N7L0852X, N7M0130X, N8A0145X, N8A0336X, N7L0931X, N7M0639X, N8A0796X & N8B0993X

    Distribution

    Nationwide U.S.A. Internationally to: Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta, Martinique, Moldova, Morocco, Namibia, Netherlands, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates & United Kingdom