Retiro De Equipo (Recall) de Device Recall Emergence Profile (EP) Healing Abutment

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 3i, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Profile Healing Abutment - Product Code NHA
  • Causa
    Mis-labeling: labeled tha53 device packaging may contain itha53 devices (the itha53 is designed to be used with an internally hexed implant--the tha53 is used with an external hex platform).
  • Acción
    Each USA customer was first contacted by telephone and then with a faxed, Urgent Medical Device Recall letter, dated 2/25/2008. Each International customer was first contacted by E-mail and then with a faxed letter. They were instructed to return the affected product to Biomet 3i.


  • Modelo / Serial
    Lot Number: 770147
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
  • Descripción del producto
    BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL
  • Manufacturer


  • Dirección del fabricante
    Biomet 3i, Inc., 4555 Riverside Drive, Palm Beach Gardens FL 33410
  • 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