Events

Retiro De Equipo (Recall) de PROVIDE PROTECTION CAP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BIOMET 3I 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
    130066
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-09-21
  • 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
    Through investigatin biomet 3i determined that the provided protection caps (ppc***) and the provide impression copings (pic***) have not demonstrated adequate biocompatibility . in that the items were both found to elicit a cytotoxic response (grade 4).

Device

PROVIDE PROTECTION CAP
  • Modelo / Serial
    Model Catalog: PPC484 (Lot serial: More than 10 contact manuf.); Model Catalog: PPC654 (Lot serial: More than 10 contact manuf.); Model Catalog: PPC655 (Lot serial: More than 10 contact manuf.); Model Catalog: PPC485 (Lot serial: More than 10 contact manuf.)
  • Descripción del producto
    PROVIDE PROTECTION CAP
  • Manufacturer
    BIOMET 3I CANADA INC.

Manufacturer

BIOMET 3I CANADA INC.
  • Dirección del fabricante
    ST. LAURENT
  • 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