Events

Retiro De Equipo (Recall) de HOWMEDICA MODULAR RESECTION SYSTEM - PROXIMAL TIBIA

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
    40014
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2010-04-19
  • 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
    Stryker has become aware of an increased trend in the frequency of hmrs stem fractures which occur most often between the collar and the first screw hole on the stem. the fractures occurred when the anchorage stem was used in either the distal femur proximal femur or the proximal tibia. the anchorage stem can be used in either a fixed hinge or a rotating hinge knee construct. the root cause of this issue is that the labeling on the product is inadequate to preclude inappropriate patient selection for the device design.

Device

HOWMEDICA MODULAR RESECTION SYSTEM - PROXIMAL TIBIA
  • Modelo / Serial
    Model Catalog: 6367-4-013 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-012 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-011 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-019 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-017 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-112 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-015 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-014 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-013 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-012 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-115 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-114 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-113 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-111 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-014 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-015 (Lot serial: all lot/serial numbers);
  • Descripción del producto
    Stryker HMRS Anchorage Pieces
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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