Device Recall Tibial Impact Pad

  • Modelo / Serial
    Item No. 42539909100; Lot No. (UDI No.): 63517759 ((01) 00880304810242 (10) 63517759), 63555750 ((01) 00880304810242 (10) 63555750), 63555752 ((01) 00880304810242 (10) 63555752), 63561883 ((01) 00880304810242 (10) 63561883), 63561884 ((01) 00880304810242 (10) 63561884), 63594911((01) 00880304810242 (10) 63594911), 63594914 ((01) 00880304810242 (10) 63594914), 63698564 ((01) 00880304810242 (10) 63698564), 63705328 ((01) 00880304810242 (10) 63705328)
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, UK.
  • Descripción del producto
    Persona Partial Knee System || Product Usage: || The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer 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