Device Recall Radiesse

  • Modèle / numéro de série
    Model number: 8063M0K1, Lot #100088744.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Merz North America, Inc., 6501 Six Forks Rd, Raleigh NC 27615-6515
  • Société-mère du fabricant (2017)
  • Source
    USFDA