Events

Retiro De Equipo (Recall) de Teflon Tube T2 Humerus, Sterile

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-00438-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-25
  • 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-00438-1
  • 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 shelf life study, it was found that particular lots of product failed a dye penetration test demonstrating a deficient seam in the sterile packaging. the seams of the pouches made by one supplier were confirmed to be within specification and do not exhibit any non-conformance. the in-house made cross seam was confirmed to be manufactured out of specification. thus these lots have been deemed as having potentially insufficient packaging integrity and therefore regarded to be unsterile.
  • Acción
    Stryker is notifying surgeons of the issue and provided advice on patient follow up. This action has been closed-out on 04/05/2017

Device

Teflon Tube T2 Humerus, Sterile
  • Modelo / Serial
    Teflon Tube T2 Humerus, SterileCatalogue Number: 18060073SLot Number: K0432D3ARTG Number: 139623
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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