Device Recall NEXGEN COMPLETE KNEE SOLUTION POSTERIOR REFERENCING SIZER

  • Modèle / numéro de série
    REF 00-5901-040-00, Lots 61510769, 61558673, 61584439, 61584919 and 61610687.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    Posterior Referencing Instrumentation for the NEXGEN¿ COMPLETE KNEE SOLUTION POSTERIOR REFERENCING SIZER, REF 00-5901-040-00, 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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    REF 00-5901-040-10, Lots 61505400, 61558201, 61570225, 61574608, 61580669, 61585371 and 61594877
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    Posterior Referencing Instrumentation for the NEXGEN¿ COMPLETE KNEE SOLUTION POSTERIOR REFERENCING SIZER Boom, REF 00-5901-040-10, 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