Events

Retiro De Equipo (Recall) de ITST FEMORAL NAILS

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
    31559
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-03-03
  • 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 initiating a field action for sterile-packaged implants in two different package configurations due to packaging design verification test failures. specifically multiple test samples from each of the two configurations failed simulated distribution and shipping testing. the devices impacted are generally the heaviest outlier sizes within the respective product family.

Device

ITST FEMORAL NAILS
  • Modelo / Serial
    Model Catalog: 00-2257-480-04 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog: 00-2257-500-04 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog: 00-2257-500-14 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog: 00-2257-480-14 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog: 00-2252-440-15 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog: 00784301508 (Lot serial: BEFORE 2027/03 (00784301508)); Model Catalog: 00-2252-400-16 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog: 00-2252-380-16 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog: 00-2252-360-16 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog: 00-2253-440-15 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog: 00-2252-500-16 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog: 00-2252-500-15 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog: 00-2252-480-16 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog: 00-2252-480-15 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog: 00-2252-460-16 (Lot serial: ALL BEFORE 2027/03/01); Model Catalog:
  • Descripción del producto
    ITST FIXATION FEMORAL NAIL;M/DN INTRAMEDULLAR FEMORAL RECON NAIL;VERSYS HIP REVISION FEMORAL STEM BEADED;SEGMENTAL SYSTEM FLUTED STEM EXT STRAIGHT;SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSION;ZMR HIP XL POROUS STEM NITRIDED BOWED;SEGMENTAL SYSTEM FL
  • 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