Device Recall Arthrotek Interference Screw

  • Modelo / Serial
    Catalog Number: 909668 Lot Number Identification: 716710
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.
  • Descripción del producto
    TUNNELOC ROUND HEAD INTERFERENCE SCREW || 8MMX25MM || Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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