Device Recall Anatomical Shoulder" Domelock

  • Modelo / Serial
    Item Number: 01.04227.005 Lot Numbers: 2792457 2794578 2812029 2817212 2844463 2794576 2794579 2815118 2817213 2847568 2794577 2794580 2815119 2832862
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution to AZ, CA, CO, GA, IL, KS, KY, MA, MD, MO, OH, PA, TN, and TX.
  • Descripción del producto
    Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. || The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. || The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • 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