Retiro De Equipo (Recall) de PERSONA THE PERSONALIZED KNEE SYSTEM CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIMS

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
    117438
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-12-16
  • País del evento
  • 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 this notification due to the discovery of persona tibial articular surface provisional (tasp) shims with missing ball bearings. repeated cycles using sonic cleaning can break down the ball bearing retention feature (swage) on the shim. to prevent this from occurring persona tasp shims must be manually cleaned and inspected per product insert 87-6203-991-22.

Device

  • Modelo / Serial
    Model Catalog: 42-5279-002-02 (Lot serial: 62656038); Model Catalog: 42-5279-002-00 (Lot serial: 62656038); Model Catalog: 42-5279-006-04 (Lot serial: 62675186); Model Catalog: 42-5279-006-02 (Lot serial: 62675186); Model Catalog: 42-5279-006-00 (Lot serial: 62675186); Model Catalog: 42-5279-004-04 (Lot serial: 62675186); Model Catalog: 42-5279-004-02 (Lot serial: 62675186); Model Catalog: 42-5279-004-00 (Lot serial: 62675186); Model Catalog: 42-5279-002-04 (Lot serial: 62675186); Model Catalog: 42-5279-002-02 (Lot serial: 62675186); Model Catalog: 42-5279-002-00 (Lot serial: 62675186); Model Catalog: 42-5279-006-04 (Lot serial: 62624341); Model Catalog: 42-5279-006-02 (Lot serial: 62624341); Model Catalog: 42-5279-006-00 (Lot serial: 62624341); Model Catalog: 42-5279-004-04 (Lot serial: 62624341); Model Catalog: 42-5279-004-02 (Lot serial: 62624341); Model Catalog: 42-5279-004-00 (Lot serial: 62624341); Model Catalog: 42-5279-002-04 (Lot serial: 62624341); Model Catalog: 42-5279-002-02 (Lot serial: 62624341
  • Descripción del producto
    PERSONA CONSTRAINED TASP SHIMS
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
  • 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