BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2335-2021 · Initiated July 23, 2021

    Recall

    Recall Number
    Z-2335-2021
    Event Number
    88395
    Firm
    BioMimetic Therapeutics, LLC
    FEI Number
    3003897776
    Product Code
    NOX
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 23, 2021
    Terminated
    September 4, 2024
    Address
    389 Nichol Mill Ln, # A, Franklin, TN, 37067-4882

    Description

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

    Reason

    The kit contains the wrong vial tray in the package.

    Action

    Recall communication was sent out via FedEx Priority Overnight. Customers are instructed to immediately quarantine all recalled products they have and return all affected product to the recalling firm's Arlington, TN Warehouse as soon as possible. If they have further distributed the affected product, they are instructed to notify the applicable parties at once about this recall. They may copy and distribute the notification letter and the recalling firm will work directly with them to collect the recalled items.

    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