Events

Retiro De Equipo (Recall) de VANGUARD TOTAL KNEE SYSTEM - PS OPEN BOX INTERLOK - FEMORAL IMPLANTS

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
    53191
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-01-06
  • 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 biomet is conducting a lot specific medical device field action for vanguard knee system ps open box femoral components due to inadequate line clearance at the supplier between april 5 2016 and september 1 2016. as a result the packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). it is highly detectable at the point of use that the device was incorrectly labelled. the estimated rate of occurrence is 0.001% (<1 in 1000 products).

Device

VANGUARD TOTAL KNEE SYSTEM - PS OPEN BOX INTERLOK - FEMORAL IMPLANTS
  • Modelo / Serial
    Model Catalog: 183133 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183132 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183130 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183128 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183126 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183124 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183102 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183113 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183112 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183110 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183108 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183106 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183104 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183122 (Lot serial: >100 LOT NUMBERS CONTACT MFR)
  • Descripción del producto
    VANGUARD TOTAL KNEE SYSTEM-PS OPEN BOX FEMORAL COMPONENTS
  • 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