Device Recall Active Articulation ArComXL Polyethylene Bearings

  • Modèle / numéro de série
    Item XL-200152 Lot 339260 UDI (01)00880304491366(17)210713(10)339260
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    USA (nationwide) and Internationally to ARGENTINA
  • Description du dispositif
    Active Articulation ArComXL Polyethylene Bearings || Active Articulation ArComXL Bearings item XL-200152
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Zimmer 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