Events

Retiro De Equipo (Recall) de Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts during hip arthroplasty)

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-2016-RN-00808-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-15
  • 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-2016-RN-00808-1
  • 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
    During steam sterilisation validation with 3 half cycles (2 minutes, 132°c), it was identified that the trident constrained liner impactor tips do not meet the required sterility assurance level (sal) of 10-6.Please note that these instruments are sterilised at the hospital prior to surgery and are not distributed as sterile from stryker to customers. due to this inability to meet the sal, the instrument may be non-sterile and this could lead to a possible infection.
  • Acción
    Stryker is advising users to inspect stock and quarantine any affected product for return. Stryker is providing information about alternative surgical methods of locking the insert into the shell. This action has been closed-out on 28/02/2018.

Device

Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts dur...
  • Modelo / Serial
    Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts during hip arthroplasty)Item Numbers: 21992022, 21992028, 21992032All Lot Numbers affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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