Device Recall Instinct Java System

  • Modelo / Serial
    All lots
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US (nationwide)-including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, ,MD, MA, MI, MN,MO, NV, NH, NY, NC, OH, OK,. PA, TN,TX, WA, and WI.
  • Descripción del producto
    Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . || Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Spine, Inc., 7375 Bush Lake Rd, Minneapolis MN 55439-2027
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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