BEUDAMED
    FDA Enforcement Class II Ongoing

    Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

    Recall: Z-1329-2014 · Reported April 9, 2014

    Enforcement

    Recall Number
    Z-1329-2014
    Event ID
    67736
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2014
    Initiation Date
    February 19, 2014
    Classification Date
    April 3, 2014
    Address
    US Highway 22 West, N/A, Somerville, NJ, 08876, United States

    Description

    Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

    Reason

    The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.

    Code Info

    Product Code PCDB1 - Lot number - GGG157 Product Code PCDT1 - Lot number - GGG158 Product Code PCDJ1 - Lot number -GGG159

    Distribution

    US Distribution including the states of FL, NJ, MO, IL, PA, NC. TX, TN, WA, ID, UT, WV, MS. CA, AL, MA. GA, LA and OK.

    Quantity

    223 units