Events

Retiro De Equipo (Recall) de RESTORATION MODULAR HIP SYSTEM - MODULAR CALCAR BODIES

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por STRYKER CANADA LP.

¿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
    78445
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-07-03
  • 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
    The third party supplier for material used to manufacture the restoration modular components has demonstrated poor process control which has raised concerns about the quality of the raw material supplied. as a precaution and due to the potential impact on the mechanical properties of the affected products stryker is recalling all products manufactured from material supplied by this supplier.

Device

RESTORATION MODULAR HIP SYSTEM - MODULAR CALCAR BODIES
  • Modelo / Serial
    Model Catalog: 6276-4-131 (Lot serial: T80551AA); Model Catalog: 6276-4-221 (Lot serial: T80998AC); Model Catalog: 6276-4-225 (Lot serial: T80551AA); Model Catalog: 6276-4-119 (Lot serial: T80554AA); Model Catalog: 6276-4-123 (Lot serial: T80554AA); Model Catalog: 6276-4-127 (Lot serial: T80554AA); Model Catalog: 6276-4-131 (Lot serial: T80554AA); Model Catalog: 6276-4-221 (Lot serial: T80554AA); Model Catalog: 6276-4-225 (Lot serial: T80554AA); Model Catalog: 6276-4-119 (Lot serial: T80998AA); Model Catalog: 6276-4-123 (Lot serial: T80998AA); Model Catalog: 6276-4-127 (Lot serial: T80998AA); Model Catalog: 6276-4-131 (Lot serial: T80998AA); Model Catalog: 6276-4-221 (Lot serial: T80998AA); Model Catalog: 6276-4-225 (Lot serial: T80998AA); Model Catalog: 6276-4-119 (Lot serial: T80998AC); Model Catalog: 6276-4-123 (Lot serial: T80998AC); Model Catalog: 6276-4-127 (Lot serial: T80998AC); Model Catalog: 6276-4-131 (Lot serial: T80998AC); Model Catalog: 6276-4-127 (Lot serial: T80551AA); Model Catalog: 6276-4-1
  • Descripción del producto
    RESTORATION MODULAR CALCAR BODIES
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Dirección del fabricante
    HAMILTON
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HC