Events

Retiro De Equipo (Recall) de OSTEONICS RESTORATION HIP SYSTEM - GAP ACETABULAR CUP PLATE SCREW

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
    75337
  • 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
    Stryker has become aware that the third party supplier for material used to manufacture the cancellous bone screws and gap plate screw did not comply with metallurgical requirements outlined in the astm standards for titanium surgical implants. as such areas of modified material properties may result which may affect the intended use of the product. although testing demonstrated the affected lots to have shear strength equivalent to screws manufactured from non-affected material the potential for variablity of the material used in manufacturing the affected lots could compromise the strength.

Device

OSTEONICS RESTORATION HIP SYSTEM - GAP ACETABULAR CUP PLATE SCREW
  • Modelo / Serial
    Model Catalog: 2080-0020 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0025 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0030 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0035 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0040 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0045 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0050 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0055 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2080-0060 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6516 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6520 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6525 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6530 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6535 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6540 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 2030-6545 (Lot serial: > 10 NUMBE
  • Descripción del producto
    GAP PLATE SCREW
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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