BEUDAMED
    FDA Enforcement Class II Terminated

    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

    Recall: Z-0759-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0759-2017
    Event ID
    75693
    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 16, 2016
    Classification Date
    December 14, 2016
    Termination Date
    December 13, 2017
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186, United States

    Description

    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

    Reason

    The devices wings may become partially detached from the EFx Shield during use.

    Code Info

    Product Code: EFX002, Lot numbers: 3264480000, 3269990000, 3270100000.

    Distribution

    Domestic; US Nationwide; International: Belgium, Canada.

    Quantity

    2265 units