BEUDAMED
    FDA Enforcement Class II Terminated

    Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.

    Recall: Z-0113-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0113-2017
    Event ID
    75119
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Osteogenics Biomedical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2016
    Initiation Date
    September 7, 2016
    Classification Date
    October 18, 2016
    Termination Date
    December 23, 2016
    Address
    4620 71st St, Bldg 75-77, Lubbock, TX, 79424-2230, United States

    Description

    Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.

    Reason

    The device has the potential to be packaged in the wrong product box.

    Code Info

    Lot 47295

    Distribution

    Worldwide Distribution - US Distribution and to the countries of : Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK.

    Quantity

    32 boxes