Events

Retiro De Equipo (Recall) de AVS PL SPACER (Used as an aid in spinal fixation)

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-2014-RN-01131-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-10-23
  • 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-2014-RN-01131-1
  • 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
    The above catalogue numbers are specific to the us and supplied with the us labelling which has a different indication then those devices supplied outside of the us. specifically, the us versions indicated use with autogenous bone graft in patients with degenerative disc disease (ddd) at one level or two contiguous levels from l2 to s1. the australian indication does not include the limit to the contiguous levels or spinal region (l2-s1).
  • Acción
    Stryker is requesting their customer to identify and return any affected stock. This action has been closed-out on 01/03/2016. This action has been closed-out on 01/03/2016.

Device

AVS PL SPACER (Used as an aid in spinal fixation)
  • Modelo / Serial
    AVS PL SPACER (Used as an aid in spinal fixation)AVS PL SPACER 7 X 20 X 4° 9MMCatalogue Number: 48340074Lot Numbers: 30646, 33494, 39184AVS PL SPACER 8 X 20 X 4° 9MMCatalogue Number: 48340084Lot Numbers: 33549, 38164, 38652, 39007, 39160AVS PL SPACER 7 X 25 X 4° 8MMCatalogue Number: 48345074Lot Number: 39188AVS PL SPACER 8 X 25 X 4° 8MMCatalogue Number: 48345084Lot Numbers: 39150, 38183ARTG Number: 178870
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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