BEUDAMED
    FDA Enforcement Class II Terminated

    Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.

    Recall: Z-0339-2019 · Reported November 7, 2018

    Enforcement

    Recall Number
    Z-0339-2019
    Event ID
    81238
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Medical Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 7, 2018
    Initiation Date
    September 25, 2018
    Classification Date
    October 31, 2018
    Termination Date
    June 4, 2020
    Address
    400 N Daniels Way, N/A, Bloomington, IN, 47404-9155, United States

    Description

    Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.

    Reason

    The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.

    Code Info

    GPN: G36230

    Distribution

    US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.

    Quantity

    9834 total