Events

Retiro De Equipo (Recall) de Device Recall InnerVue Diagnostic Scope System

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
    57965
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1588-2011
  • Fecha de inicio del evento
    2011-02-10
  • Fecha de publicación del evento
    2011-03-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97863
  • 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
    laparoscope - Product Code HRX
  • Causa
    The cannula could not be connected to the scope and scopes disengage during use. the outer hub of innervue scopes may become detached from the inner hub of the scopes during assembly of the scope to the innervue hand piece. this condition may prevent the innervue scope from being securely attached to the innervue hand piece.
  • Acción
    On 2/10/2011, Biomet issued an "URGENT MEDICAL DEVICE NOTICE" to their Direct Accounts instructing customers to identify and discontinue use of the recalled products and return them to Biomet. Response forms were provided.

Device

Device Recall InnerVue Diagnostic Scope System
  • Modelo / Serial
    PART NUMBER 922140, LOT NUMBERS-337350, 381090, 381110, 337340, 751560, 751550, 707500, 707520, 707480, 073120, 073140
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution USA nationwide and to the Netherlands
  • Descripción del producto
    Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM, PRODUCT NUMBER 922140, STERILE
  • Manufacturer
    Biomet, Inc.

Manufacturer

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