Device Recall Zimmer Natural Nail System

Fabricante

  • Dirección del fabricante
    Zimmer, 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

23 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
    Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile
  • Manufacturer
  • Modelo / Serial
    Lot Number: 63606634
  • 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
    Zimmer Natural Nail System Calibrated Drill Short 4.9 mm, Item Number/EDI 00249006449, Nonsterile
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: 63541085, 63565537, 63586553, 63586554, 63635381,  63635382, 63660536, 63329874, 63329875, 63343934, 63343935,  63361695, 63370747, 63388956, 63399691, 63399692, 63413799, 63413801, 63413803, 63413804 & 63499022.
  • 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
    Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, Item Number/EDI 00249007543, Nonsterile
  • Manufacturer
  • Modelo / Serial
    All Lot Numbers Expiry Date Before April 2022
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore
  • Descripción del producto
    Zimmer Natural Nail System Tear Drop Guide Wire || 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 || Product Usage: || The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.
  • Manufacturer
  • Modelo / Serial
    All Lot Numbers Expiry Date Before March 2022
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore
  • Descripción del producto
    Zimmer Natural Nail System Tear Drop Guide Wire || 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 || Product Usage: || The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.
  • Manufacturer
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