Events

Retiro De Equipo (Recall) de NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE TIBIAL BROACH INPACTOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ZIMMER BIOMET CANADA 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
    48447
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-04-17
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    There is a potential for the thumb pin detaching from these two instruments (nexgen complete knee solution stemmed tibial and rotating hinge knee tibial broach impactors) during impact. this presents the possibility of the thumb pin being left in the surgical site. the thumb pin is secured by epoxy and as the instrument ages the epoxy bond may fail allowing the pin to detach from the instrument.

Device

NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE TIBIAL BROACH INPACTOR
  • Modelo / Serial
    Model Catalog: 00-5881-080-00 (Lot serial: 79006000); Model Catalog: 00-5881-080-00 (Lot serial: 60777631); Model Catalog: 00-5881-080-00 (Lot serial: 60067099); Model Catalog: 00-5881-080-00 (Lot serial: 50088600); Model Catalog: 00-5881-080-00 (Lot serial: 60009328); Model Catalog: 00-5881-080-00 (Lot serial: 52153800); Model Catalog: 00-5881-080-00 (Lot serial: 60040337); Model Catalog: 00-5977-011-00 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Descripción del producto
    NEXGEN COMP KNEE ROTATING HINGE KNEE
  • Manufacturer
    ZIMMER BIOMET CANADA INC.

Manufacturer

ZIMMER BIOMET CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • 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
    HC