BEUDAMED
    FDA Enforcement Class II Terminated

    C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.

    Recall: Z-1936-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1936-2013
    Event ID
    65698
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2013
    Initiation Date
    July 19, 2013
    Classification Date
    August 9, 2013
    Termination Date
    March 18, 2016
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929, United States

    Description

    C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.

    Reason

    Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

    Code Info

    Product lines with lot number 10405513 and higher

    Distribution

    USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.

    Quantity

    32,834 units