BEUDAMED
    FDA Recall 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 · Initiated November 18, 2016

    Recall

    Recall Number
    Z-0764-2017
    Event Number
    75735
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    GDT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 18, 2016
    Terminated
    November 24, 2017
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    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.

    Action

    The firm, Telexflex Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 11/18/2016 to its Consignees/Customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any affected products; complete and return the Recall Acknowledgement Form by fax to 1-855-419-8507, Attn: Customer Service or email to: [email protected] (even if you do not have any affected product) and return the product with the completed Recall Acknowledgement Form. A customer service representative will contact you with a RGA # and provide instructions for the return of the product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

    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)