Events

Retiro De Equipo (Recall) de Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants)

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-00554-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-26
  • 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-00554-1
  • 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
    There is a potential that the packaging integrity (sterile barrier) of the packaging type kit i may be compromised by transportation. a compromised sterile barrier could result in the surgeon selecting a back-up device or, if not recognised, an unintended implantation of a potentially non sterile device. the packaging type kit i consists of a white cardboard box, an outer peel pouch, and an inner peel pouch.
  • Acción
    Stryker is notifying hospitals and surgeons of the issue and recovering stock supplied to hospitals. Surgeons are advised of the potential hazards involved in the implantation of devices where the sterile barrier has been breached. This action has been closed-out on 18/08/2016.

Device

Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants)
  • Modelo / Serial
    Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants)rHead Recon Stem Implant non-coated:Size 1 Item: RCNS160, Lot: 19804S2Size 2 Item: RCNS260, Lot: 19773-S2Size 3 Item: RCNS360, Lot: 19807S2Bipolar stem implant #1 Item RCNS1, Lot 19716S2Bipolar stem implant #3 Item RCNS3, Lot19720-S2Bipolar stem implant #4 Item RCNS4, Lot19816-S2Radial stem implant #1 Item RHAS1, Lot19778S2 Radial stem implant #4 Item RHAS4, Lot19814-S2
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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