BEUDAMED
    FDA Enforcement Class II Terminated

    AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343

    Recall: Z-2335-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2335-2021
    Event ID
    88395
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioMimetic Therapeutics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 1, 2021
    Initiation Date
    July 23, 2021
    Classification Date
    August 23, 2021
    Termination Date
    September 4, 2024
    Address
    389 Nichol Mill Ln # A, N/A, Franklin, TN, 37067-4882, United States

    Description

    AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343

    Reason

    The kit contains the wrong vial tray in the package.

    Code Info

    Model Number K30003010, Lot 1706343

    Distribution

    US Nationwide distribution in the states of AK, CA, CO, FL, GA, IA, ID, IL, IN, MA, MI, MN, NC, NJ, NM, NY, OH, OR, PA, TX, UT, VA, WA, and WI.

    Quantity

    499 units