BEUDAMED
    FDA Recall 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 · Initiated May 20, 2016

    Recall

    Recall Number
    Z-2607-2016
    Event Number
    74252
    Firm
    Merz North America, Inc.
    FEI Number
    1012187
    Product Code
    LMH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 20, 2016
    Posted
    August 19, 2016
    Terminated
    May 8, 2017
    Address
    6501 Six Forks Rd, Raleigh, NC, 27615-6515

    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.

    Action

    Merz sent an Urgent Medical Device Recall Letter dated May 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the enclosed response form and return via fax to (262) 835-3330 or email to [email protected]. For questions contact Merz at (262) 835-3300 ext. 2627.

    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