BEUDAMED
    FDA Enforcement Class II Terminated

    OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

    Recall: Z-1223-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1223-2019
    Event ID
    82487
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Matrix Surgical Holdings, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 8, 2019
    Initiation Date
    January 30, 2019
    Classification Date
    April 26, 2019
    Termination Date
    June 23, 2020
    Address
    4025 Welcome All Rd Sw Ste 120, N/A, Atlanta, GA, 30349-1876, United States

    Description

    OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

    Reason

    Product mislabeling.

    Code Info

    OP9519 / Lot # 00855421005864 021050617

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of Florida and Massachusetts and countries of Argentina, Chile, Colombia, Iran, Mexico, Norway, Taiwan, and Turkey.

    Quantity

    46