Events

Retiro De Equipo (Recall) de STERLING BURRS AND ROUTER

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

¿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
    55207
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-12-21
  • 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
    This recall has been initiated due to an assembly error caused by the inadvertent mixing of two sizes of bearings which occurred on the manufacturing line. conmed received 10 complaints of metal shavings coming from the burs during use due to contact between the bur and the hood of the prebent bur assembly. this could potentially render the device inoperable and could potentially cause a minor injury to the patient if the metal debris drops into the patient operative site. in no instance has it been reported to conmed corporation that this issue has resulted in illness or injury. all lots codes of catalog no. hps-hb11 hps-hb12 and hps-hb13 (hip preservation system signature series prebent burs) manufactured from june 18 2014 through to october 2 2015 are being removed from the market by this recall action.

Device

STERLING BURRS AND ROUTER
  • Modelo / Serial
    Model Catalog: HPS-HB11 (Lot serial: ALL LOTS); Model Catalog: HPS-HB13 (Lot serial: ALL LOTS)
  • Descripción del producto
    PREBENT BURS
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    HC