BEUDAMED
    FDA Enforcement Class II Terminated

    Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.

    Recall: Z-2607-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2607-2016
    Event ID
    74252
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merz North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    May 20, 2016
    Classification Date
    August 19, 2016
    Termination Date
    May 8, 2017
    Address
    6501 Six Forks Rd, Raleigh, NC, 27615-6515, United States

    Description

    Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.

    Reason

    Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.

    Code Info

    Model number: 8063M0K1, Lot #100088744.

    Distribution

    US Nationwide Distribution in the states of AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT and WA.

    Quantity

    1,591 units