BEUDAMED
    FDA Recall Terminated

    Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.

    Recall: Z-1523-2018 · Initiated February 23, 2018

    Recall

    Recall Number
    Z-1523-2018
    Event Number
    79662
    Firm
    Sofradim Production 116 avenue de Formans Trevoux France
    FEI Number
    3003521774
    Product Code
    FTL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 23, 2018
    Posted
    April 26, 2018
    Terminated
    May 12, 2020

    Description

    Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.

    Reason

    There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.

    Action

    All consignees were notified via Federal Express or certified mail on February 23, 2018. Customers were advised of the added warning on the product labeling. Customers were requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. Customers with questions were directed to contact their Medtronic Representative, or Customer Service at 800-962-9888, option 2.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution to the states of: CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, PA, TN, TX, VA, WA and WI, and to the countries of : Belgium, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, Russian Federation, Spain, Switzerland, and UK.

    Quantity

    703