Events

Retiro De Equipo (Recall) de WAXING COPING CONTOUR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ZIMMER DENTAL 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
    47359
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-07-31
  • 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 medical device field correction for various dental products due to several parts being shipped to the customer with only standard instructions for use (ifus). all listed products were missing supplemental ifus. affected customers are being provided with instructions on how to obtain the supplemental ifus from the website ifu.Zimmerdental.Com or by contacting zimmer's e-labeling services section.

Device

WAXING COPING CONTOUR
  • Modelo / Serial
    Model Catalog: ZOCWAX4S (Lot serial: 62602470); Model Catalog: ZOCWAX3S (Lot serial: 62602470); Model Catalog: ZOCWAX4S (Lot serial: 63432495); Model Catalog: ZOCWAX3S (Lot serial: 63432495); Model Catalog: ZOCWAX4S (Lot serial: 63155008); Model Catalog: ZOCWAX3S (Lot serial: 63155008); Model Catalog: ZOCWAX4S (Lot serial: 63240239); Model Catalog: ZOCWAX3S (Lot serial: 63240239); Model Catalog: HLA4G (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: ZOCWAX3S (Lot serial: 63331292); Model Catalog: 2224 (Lot serial: 63241114); Model Catalog: 2223 (Lot serial: 63241114); Model Catalog: 2224 (Lot serial: 63426543); Model Catalog: 2223 (Lot serial: 63426543); Model Catalog: 2224 (Lot serial: 63321266); Model Catalog: 2223 (Lot serial: 63321266); Model Catalog: 2224 (Lot serial: 63503028); Model Catalog: 2223 (Lot serial: 63503028); Model Catalog: 2224 (Lot serial: 63426542); Model Catalog: 2223 (Lot serial: 63426542); Model Catalog: ZOAT34 (Lot serial: 63145351); Model Catalog: HLA5G (Lot serial: >100 NUMBE
  • Descripción del producto
    WAXING COPING CONTOUR;TAPERED SCREW-VENT GOLD ABUTMENTS;THREAD RETRIEVER DRILL AND GUIDE SLEEVES;ABUTMENT TRY-IN CONTOUR;ZIMMER DENTAL ONE-PIECE IMPLANT
  • Manufacturer
    ZIMMER DENTAL INC.

Manufacturer

ZIMMER DENTAL INC.
  • Dirección del fabricante
    CARLSBAD
  • 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