BEUDAMED
    FDA Enforcement Class II Terminated

    Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM

    Recall: Z-2174-2017 · Reported June 7, 2017

    Enforcement

    Recall Number
    Z-2174-2017
    Event ID
    76921
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon Endo-Surgery Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 7, 2017
    Initiation Date
    March 31, 2017
    Classification Date
    May 31, 2017
    Termination Date
    May 3, 2018
    Address
    4545 Creek Rd, Blue Ash, OH, 45242-2803, United States

    Description

    Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM

    Reason

    There is a risk that the pinion gear in the device could fail under extreme use cases.

    Code Info

    N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G

    Distribution

    Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.

    Quantity

    792 units