Events

Retiro De Equipo (Recall) de Tritanium PL 6mm

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-2018-RN-00735-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-06-22
  • 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-2018-RN-00735-1
  • 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 australia has discovered that two (2) lots of tritanium-pl cages, part number 48950066 (lot # a8am) and part number 48954066 (lot # a8t2), were shipped and sold to australia without market release approval. the tritanium-pl cage product family has been registered and approved in australia. however, the specific part numbers 48950066 and 48954066 were not registered in australia.
  • Acción
    Stryker Australia is requesting recipients of the letter to confirm whether they possess any affected stock and to inform any parties who may have received affected stock and to inform Stryker of this using the supplied response forms. A hazard alert is also being issued.

Device

Tritanium PL 6mm
  • Modelo / Serial
    Tritanium PL 6mm Item Numbers:48950066 & 48954066Lot Numbers: A8AM, A8T2ARTG Number: 265560(Stryker Australia Pty Ltd - Spinal cage)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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