Events

Retiro De Equipo (Recall) de Xia 3 Titanium Torque Wrench

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia Pty 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
    RC-2015-RN-00745-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-17
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00745-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Stryker has received reports that the hex tip of the listed torque wrenches have been fracturing during final tightening. the hex tip of the wrench has broken off and separated from the main tube.The manufacturer has identified four possible hazardous situations:· delay in surgery time (< 5 minutes) if an alternative torque wrench is needed· debris of non-implantable grade material falling into the wound· over/under-tightening of the blocker if an alternate instrument is not available· accidental implanting of the hex tip.
  • Acción
    Customers are requested to quarantine all affected lots. A Stryker representative will contact all affected customers to arrange for collection of the affected products. Unaffected replacement units will be provided. This action has been closed-out 18/04/2017.

Device

Xia 3 Titanium Torque Wrench
  • Modelo / Serial
    Xia 3 Titanium Torque WrenchCatalogue Number: 48237028Lot Numbers: 098525, Xia 3 Torque Wrench ShortCatalogue Number: 482397028Lot Numbers: 11E035ARTG Number: 160151
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA