Device Recall OSS FINN Proximal Femoral Trial 7 cm

  • Modelo / Serial
    All lots. Lots 009000, 030690, 115360, 132710, 154030, 170310, 252710, 282860, 397260, 404980, 407530, 422190, 444030, 444040, 487930, 506430, 518140, 536080, 635560, 650520, 704190, 837020, 839630, 849100, 886310, 895790, 895800 and 915370.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, Australia, Belgium, Canada, Costa Rica, Finland, France, Germany, Mexico, New Zealand, Poland, South Wales, and Spain.
  • Descripción del producto
    Biomet OSS FINN Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472086. || A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 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

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    All lots. Lots 0009000, 0009010, 030700, 075980, 115370, 120220, 132720, 154040, 170330, 261920, 282870, 422200, 444060, 444070, 474100, 488420, 506450, 509800, 536090, 619840, 641440, 704200, 746940, 763780, 763870, 822300, 837030, 849110, 895810 and 958370.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, Australia, Belgium, Canada, Costa Rica, Finland, France, Germany, Mexico, New Zealand, Poland, South Wales, and Spain.
  • Descripción del producto
    Biomet OSS FINN Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472087. || A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery.
  • Manufacturer