Events

Retiro De Equipo (Recall) de Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026.

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Biomet, 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
    29565
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1411-04
  • Fecha de inicio del evento
    2004-07-12
  • Fecha de publicación del evento
    2004-08-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34120
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Causa
    The cautery cover cap may become dislodged during shipping or handling, the cautery switch may be activated and the cautery may melt or burn through the packaging pouch.
  • Acción
    Consignees were notified to inspect the devices for the defect via letter dated and faxed 7/12/04. A second letter issued 7/15/04 instructing consignees NOT to inspect the product, but to return all units.

Device

Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet ...
  • Modelo / Serial
    Arthrotek lots 049130, 300470, 278290 and 452840. Biomet lots 300450 and 228320.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    United States.
  • Descripción del producto
    Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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
    USFDA