Events

Retiro De Equipo (Recall) de ZIMMER DENTAL RETAINING 2.5MM HEX DRIVER LONG

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
    40588
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-01-27
  • 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 dental is conducting a recall of certain lots of the zimmer dental retaining 2.5mm long hex driver (catalog rhl2.5) because it may not fit into the fixture mount transfer or the internal hex of the implant. the affected product was distributed in the tapered screw-vent implant system surgical kit complete (catalog tsvkit). the affected product regardless of the lot number on the label is etched with one of the following supplier lot numbers: 62699693 and 62735177.

Device

ZIMMER DENTAL RETAINING 2.5MM HEX DRIVER LONG
  • Modelo / Serial
    Model Catalog: RHL2.5 (Lot serial: 62702589); Model Catalog: RHL2.5 (Lot serial: 62743075); Model Catalog: RHL2.5 (Lot serial: 62753787); Model Catalog: RHL2.5 (Lot serial: 62760388); Model Catalog: RHL2.5 (Lot serial: 62699693); Model Catalog: RHL2.5 (Lot serial: 62735177)
  • Descripción del producto
    ZIMMER DENTAL RETAINING LONG HEX DRIVER
  • 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