BEUDAMED
    FDA Enforcement Class II Terminated

    Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.

    Recall: Z-0820-2014 · Reported January 29, 2014

    Enforcement

    Recall Number
    Z-0820-2014
    Event ID
    67149
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Davol, Inc., Subs. C. R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2014
    Initiation Date
    January 3, 2014
    Classification Date
    January 23, 2014
    Termination Date
    December 23, 2015
    Address
    100 Crossings Blvd, Warwick, RI, 02886-2850, United States

    Description

    Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.

    Reason

    Product labeling does not match product configuration.

    Code Info

    Lot# HUXG0491, HUXH0295

    Distribution

    Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.

    Quantity

    46