Device Recall Zimmer Universal Locking System

  • Modelo / Serial
    LOT: 63297474
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
  • Descripción del producto
    Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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
    Part 00-4936-011-13, Lot 62968956 3.5MM ULS RECON PLATE 11H Part 00-4936-008-07, Lot 62968974 3.5MM ULS DUAL COMP PLT 8
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, including the states of MN, NY, MS, AL, OH, KY, ME, and NM; and, the countries of Taiwan, Korea, Singapore, El Salvador, Uruguay, Czech Republic, France, Italy, Poland, United Kingdom, South Africa, and Slovakia.
  • Descripción del producto
    Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate || Straight 11 Holes 144mm Length || Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate || 8 Holes 105mm Length. || Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
  • Manufacturer