Device Recall Palacos R

Fabricante

  • Dirección del fabricante
    Biomet Inc, 56 East Bell Dr, Warsaw IN 46582
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Cat No. 00-1113-140-01; lot 75974340
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV & WY.
  • Descripción del producto
    Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 || The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
  • Manufacturer