Biomet Series A Asymmetrical Patella size 28mm, three pegs 184791

  • Modèle / numéro de série
    Part 184791, Lot 098760, 143320, 143480, 247410, 247420, 283590, 311990
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Argentina, Australia, Canada, Chile, Costa Rica, Europe, India, Japan, Korea, and Singapore.
  • Description du dispositif
    Biomet Series A Asymmetrical Patella size 28mm, three pegs - 184791, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. Joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. || Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA