Events

Retiro De Equipo (Recall) de 3i single patient disposable drill

Según Pharmaceuticals and Medical Devices Agency, Japan, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Japan que fue producido por Zimmer · Biomet · Dental Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    2-7519
  • Fecha
    2017-06-23
  • País del evento
    Japan
  • Fuente del evento
    PMDAJ
  • URL de la fuente del evento
    http://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-7519
  • Notas / Alertas
    Japanese data is current through August 2018. All of the data comes from the Japanese Pharmaceuticals and Medical Devices Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Japan.
  • Notas adicionales en la data
    2017/7/3 Correction of "2. Target Lot, Quantity and Shipment Timing" Recovery End 2017/9/1 "4. Reason for Recovery" "5. Specific Health Damage Caused" 9. "Person in charge and Contact Correction of

Device

3i single patient disposable drill

Manufacturer

Zimmer · Biomet · Dental Inc.
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • 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
    PMDAJ