Device Recall Coonmad/Morrey

  • Modèle / numéro de série
    Catalog 32-8106-000-03; Lot 61644802
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution - USA nationwide and the countries of: Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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