Events

Retiro De Equipo (Recall) de BIOLOX OPTION CERAMIC FEMORAL HEAD TAPER 12/14

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
    44728
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-09-16
  • 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 gmbh is initiating a recall by issuing a revised instructions for use (ifu) for the biolox option ceramic femoral head system sizes 28mm to 40mm. zimmer determined that the current information as described in the ifu and in the design rational document was confusing. the system offers the option to treat primary and revision cases. in hip revision surgery the original stem could remain in situ. for this specific scenario the biolox option ifu and the design rationale document related to the heads have been revised to improve the definition for the level of allowed damage for the stem taper.

Device

BIOLOX OPTION CERAMIC FEMORAL HEAD TAPER 12/14
  • Modelo / Serial
    Model Catalog: 00877703604 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877704004 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877704003 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877704002 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877704001 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877702801 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703603 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703602 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703601 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703204 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703203 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703202 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877703201 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877702804 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 00877702803 (Lot serial: >10 NUMBERS. CONTACT MFR); Model Catalog: 008
  • Descripción del producto
    BIOLOX OPTION CERAMIC FEMORAL HEADS
  • 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