BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1936-2013 · Initiated July 19, 2013

    Recall

    Recall Number
    Z-1936-2013
    Event Number
    65698
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    FTL
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    July 19, 2013
    Posted
    August 9, 2013
    Terminated
    March 18, 2016
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929

    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

    Action

    Atrium Medical issued Recall Letter via UPS and e-mail on 7/19/13 to the accounts and field representatives. The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. A reply for is requested to be completed to acknowledge receipt to the notification. Additional language to the instructions for use (IFU) to include: Prolonged exposure to high humidity may result in increased rate of adherence of the C-QUR mesh to its handling sleeve. Store in a Controlled Room Temperature (25 C / 77 F ) or less. Brief exposure to up to 40 C (104 F ) is acceptable. Questions please contact Atrium Medical Customer Service at 1- 800- 528-7486 Monday through Friday 9:00 am to 5:00 pm EDT.

    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