BEUDAMED
    FDA Enforcement Class II Terminated

    ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

    Recall: Z-0712-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0712-2018
    Event ID
    79293
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    November 22, 2017
    Classification Date
    February 23, 2018
    Termination Date
    July 30, 2018
    Address
    40 Continental Blvd, N/A, Merrimack, NH, 03054-4332, United States

    Description

    ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

    Reason

    An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.

    Code Info

    Product Code/REF 1010306-06 Lot Number/LOT: 412298

    Distribution

    Internationally to Spain only.

    Quantity

    60 units