Device Recall Radiesse

  • Model / Serial
    Model number: 8063M0K1, Lot #100088744.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • 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.
  • Product 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Merz North America, Inc., 6501 Six Forks Rd, Raleigh NC 27615-6515
  • Manufacturer Parent Company (2017)
  • Source
    USFDA