Devices

Device Recall NEXGEN COMPLETE KNEE SOLUTION FEMORAL VALGUS ALIGNMENT GUIDE,

  • Modelo / Serial
    REF 00-5901-067-00, Lots 61516151, 61517153, 61559529, 61585375, 61587424, 61603824, 61610584, 61610623, 61625078, 61628952, 61635427, 61635428, 61655097 and 61658448.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, Germany, Japan, New Delphi and Singapore. Addendum: Finland, Switzerland, UK, Denmark, Spain, Portugal, France, Netherlands, Italy, South Africa, Norway, Spain, and Sweden.
  • Descripción del producto
    Posterior Referencing Instrumentation for the NEXGEN¿ COMPLETE KNEE SOLUTION FEMORAL VALGUS ALIGNMENT GUIDE, REF 00-5901-067-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN || This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
  • Manufacturer
    Zimmer Inc.
  • 1 Event

Fabricante

Zimmer Inc.
  • Dirección del fabricante
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • 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