Events

Retiro De Equipo (Recall) de TAPERED SCREW VENT TRABECULAR METAL IMPLANT (4.1MM X 8MM - 6.0MM X 13MM)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ZIMMER BIOMET DENTAL CANADA INC. / ZIMMER BIOMET DENTAIRE 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
    84775
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-04-23
  • 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
    Precautions have been added to the instructions for use indicating additional information regarding the placement of a 4.1mm diameter trabecular metal implant in mandibles with dense (type d1) thick inferior border. this follows a complaint where the apical tip of a 4.1mmd implant separated from the implant during surgery.

Device

TAPERED SCREW VENT TRABECULAR METAL IMPLANT (4.1MM X 8MM - 6.0MM X 13MM)
  • Modelo / Serial
    Model Catalog: TMM4B11 (Lot serial: 61992706); Model Catalog: TMM4B13 (Lot serial: 61992706); Model Catalog: TMM4B10 (Lot serial: 61973167); Model Catalog: TMM4B11 (Lot serial: 61973167); Model Catalog: TMM4B13 (Lot serial: 61973167); Model Catalog: TMM4B10 (Lot serial: 61992706); Model Catalog: TMM4B11 (Lot serial: 61977019); Model Catalog: TMM4B13 (Lot serial: 61977019); Model Catalog: TMM4B10 (Lot serial: 61977020); Model Catalog: TMM4B11 (Lot serial: 61977020); Model Catalog: TMM4B13 (Lot serial: 61977020); Model Catalog: TMM4B10 (Lot serial: 61977019)
  • Descripción del producto
    TRABECULAR METAL IMPLANTS 4.1MMD
  • Manufacturer
    ZIMMER BIOMET DENTAL CANADA INC. / ZIMMER BIOMET DENTAIRE CANADA INC.

Manufacturer

ZIMMER BIOMET DENTAL CANADA INC. / ZIMMER BIOMET DENTAIRE 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