Events

Retiro De Equipo (Recall) de VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432

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-01262-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-24
  • 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-01262-1
  • 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 a product presentation it has been recognised that a screw is not held by the screwdriver blade. the missing retaining function is caused by the inner torx of the screws partly being out of specification. investigations have revealed that screws might exceed given tolerances. a missing retaining function can lead to the surgeon having difficulties to pick the screw out of the screw rack without any further means, such as tissue forceps or other forceps, or during transfer of the screws. difficulties during pick up or transfer of the screws could potentially cause additional time under anaesthesia due to prolongation of surgery.
  • Acción
    Stryker is advising users that the affected screws can be continued to be used and will be replaced once unaffected stock is available. This action ha been closed-out on 29/08/2016.

Device

VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432
  • Modelo / Serial
    VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432Multiple Lot Numbers affectedIncluded in VariAx Compression EPS system trayCatalogue Number: 940081-TAll lot numbers affectedARTG Number: 239272
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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