Events

Retiro De Equipo (Recall) de RIA SYSTEM - REAMER HEAD STERILE

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

¿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
    55733
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-06-15
  • 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
    Synthes canada ltd. is initiating a voluntary medical device labelling recall for synthes reamer/irrigator /aspirator (ria) system technique guide (j4352). precautionary statements are being added to the "reamer /irrigator/ aspirator (ria) surgical technique guide". it was reported that the ria drive shaft tube assembly and reamer head have the potential to break when incorrectly assembled or used improperly as follows: 1. failure to fully engage the reamer to shaft at assembly prior to surgery. incorrect assembly creates a reduced reamer/shaft contact surface area in which excess rotational forces could cause breakage 2. use of ria drive shafts after the flats have become worn and rounded 3. use of any excess force beyond design limit 4. use of with an incompatible power tool.

Device

RIA SYSTEM - REAMER HEAD STERILE
  • Modelo / Serial
    Model Catalog: 352.263S (Lot serial: All revisions); Model Catalog: 352.262S (Lot serial: All revisions); Model Catalog: 352.261S (Lot serial: All revisions); Model Catalog: 352.259S (Lot serial: All revisions); Model Catalog: 352.250S (Lot serial: All revisions); Model Catalog: 352.257S (Lot serial: All revisions); Model Catalog: 352.256S (Lot serial: All revisions); Model Catalog: 352.255S (Lot serial: All revisions); Model Catalog: 352.254S (Lot serial: All revisions); Model Catalog: 352.253S (Lot serial: All revisions); Model Catalog: 352.252S (Lot serial: All revisions); Model Catalog: 352.251S (Lot serial: All revisions); Model Catalog: 352.264S (Lot serial: All revisions); Model Catalog: 352.265S (Lot serial: All revisions); Model Catalog: 352.258S (Lot serial: All revisions); Model Catalog: 314.743 (Lot serial: All revisions); Model Catalog: 314.742 (Lot serial: All revisions); Model Catalog: 314.745S (Lot serial: All revisions); Model Catalog: 314.746S (Lot serial: All revisions)
  • Descripción del producto
    RIA SYSTEM - REAMER HEAD STERILE
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC