Device Recall ECT Internal Fracture Fixation QuickConnect Drill

Fabricante

  • Dirección del fabricante
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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

6 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot Numbers: 63584061 & 63634136
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Descripción del producto
    ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: 63557936, 63566282, 63574978 & 63623144.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Descripción del producto
    ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Length, Item Number/EDI 00241002000, Nonsterile
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: 63545295, 63634139, 63634141 & 63530410.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Descripción del producto
    ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 12.5 cm Length, Item Number/EDI 00241002100, Nonsterile
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: 63306444, 63315170, 63350728, 63364047, 63377460, 63474111, 63474113, 63499659 & 63499667.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Descripción del producto
    ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length, Item Number/EDI 00241002700, Nonsterile
  • Manufacturer
  • Modelo / Serial
    Lot Number: 63510893
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Descripción del producto
    ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Length, Item Number/EDI 00241003500, Nonsterile
  • Manufacturer
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