BEUDAMED
    FDA Recall Terminated

    Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.

    Recall: Z-0366-2016 · Initiated October 26, 2015

    Recall

    Recall Number
    Z-0366-2016
    Event Number
    72585
    Firm
    Merz North America, Inc.
    FEI Number
    1012187
    Product Code
    LMH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 26, 2015
    Posted
    December 3, 2015
    Terminated
    May 8, 2017
    Address
    6501 Six Forks Rd, Raleigh, NC, 27615-6515

    Description

    Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.

    Reason

    The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

    Action

    Letters dated 11/4/2015 were sent to customers with tracking and delivery confirmation. The letter informs the customer that they may continue to safely use the affected product by referring to the USE BEFORE date.

    Distribution

    Nationwide Distribution including the states of AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, LA, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI.

    Quantity

    1,616 units