Events

Retiro De Equipo (Recall) de TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOID CASE ASSEMBLY (NOT A MEDICAL DEVICE)

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
    142709
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-06-11
  • 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
    Zimmer is conducting a market withdrawal of one lot of the trabecular metal reverse shoulder system glenoid case assembly. zimmer has received two complaints wherein a bracket on the glenoid case assembly did not allow the 40mm provisional glenosphere to fully seat in the case because the bracket was installed backwards. while the 40mm provisional does not fully seat in the case its placement would not affect transporation or sterilization of the case contents.

Device

TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOID CASE ASSEMBLY (NOT A MEDICAL DEVICE)
  • Modelo / Serial
    Model Catalog: 00-4309-080-00 (Lot serial: 56595585)
  • Descripción del producto
    TM REV. SHOULDER GLENOID CASE ASSEMBLY
  • 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