BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2174-2017 · Initiated March 31, 2017

    Recall

    Recall Number
    Z-2174-2017
    Event Number
    76921
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 31, 2017
    Terminated
    May 3, 2018
    Address
    4545 Creek Rd, Blue Ash, OH, 45242-2803

    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.

    Action

    Consignees were sent notification letters and were asked to complete the Business Reply Form (BRF).

    Distribution

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

    Quantity

    792 units