BEUDAMED
    FDA Enforcement Class II Terminated

    WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures.

    Recall: Z-0764-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0764-2017
    Event ID
    75735
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    November 18, 2016
    Classification Date
    December 14, 2016
    Termination Date
    November 24, 2017
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186, United States

    Description

    WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures.

    Reason

    Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.

    Code Info

    Product Code: 528235, Lot numbers: 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006 and 73M1500130.

    Distribution

    Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.

    Quantity

    96,402 units (9,120 ea US, 87,282 ea OUS)