Device Recall Coonmad/Morrey

  • Modelo / Serial
    Catalog 32-8106-000-03; Lot 61644802
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution - USA nationwide and the countries of: Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK.
  • Descripción del producto
    COONMAD/MORREY TOTAL ELBOW || ELBOW COMPONENT REPLACEMENT SET || BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW || ELBOW COMP REPLACEMENT-REG SET || STERILE PROD CLASS: 4100 || OPERATION:9000 || QTY/PKG:1 || Product Usage: || The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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