BEUDAMED
    FDA Enforcement Class I Terminated

    ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A

    Recall: Z-0201-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0201-2020
    Event ID
    83897
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon Endo-Surgery Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2019
    Initiation Date
    October 3, 2019
    Classification Date
    October 29, 2019
    Termination Date
    June 3, 2021
    Address
    4545 Creek Rd, Blue Ash, OH, 45242-2803, United States

    Description

    ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A

    Reason

    The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.

    Code Info

    Lot: T93Z9Y, T9411A

    Distribution

    Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.

    Quantity

    255 units