Events

Retiro De Equipo (Recall) de RESTORATION MODULAR CONE BODY TRIALS

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
    32708
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-04-19
  • 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 orthopedics has become aware that there is the potential for the presence of a burr in the last threaded feature of restoration modular cone body trials. this threaded feature mates with the trial locking bolt. to date no product experience reports have been received with regard to this issue.

Device

RESTORATION MODULAR CONE BODY TRIALS
  • Modelo / Serial
    Model Catalog: 6278-1-329 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-337 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-325 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-323 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-321 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-319 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-231 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-229 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-227 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-225 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-223 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-221 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-219 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-131 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-129 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-127 (Lot serial: >10 NUMBE
  • Descripción del producto
    RESTORATION MODULAR CONE BODY TRIALS
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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