Device Recall Vanguard Distal Cut Block

  • Modèle / numéro de série
    REF 32-487002, Lot 2561329
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - in the countries of France, Japan, Italy, Netherlands, UK , no devices distributed in the USA
  • Description du dispositif
    Vanguard Knee Instrumentation Distal Cutting Block without Handles, REF 32-487002 LOT 2561329, Biomet UK Ltd, South Wales, UK || Used to guide a saw blade in resecting the the distal femor. Intended to be used with a femoral alignment guide guide.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biomet U.K., Ltd., Waterton Industrial Estate, Bridgend, South Wales United Kingdom
  • 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