Events

Retiro De Equipo (Recall) de Triathlon CR/PS Inserts & ASYM Patella, Brunswik Captive Cemented Cup, Avon Patella Medium & Patella Femoral Joint, HMRS Humerus Bearing, MRH Bumper Neutral/3 Degrees & Tibial Inserts, Scorpio CR Tibial Insert & Medialised Patella, Duracon PCA Femoral, Patella & Constrain Inserts, Scorpio PS Tibial & Flex PS/+PS/+PCS Inserts (total knee, hip, shoulder components) and Artisan Bone Plug

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-2012-RN-01003-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-04
  • 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-2012-RN-01003-1
  • 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
    Stryker orthopaedics has become aware of a potential packaging issue associated with various products, potentially affecting sterility of the devices.
  • Acción
    Quarantine the affected devices identified in customer letter from Stryker.

Device

Triathlon CR/PS Inserts & ASYM Patella, Brunswik Captive Cemented Cup, Avon Patella Medium & Pate...
  • Modelo / Serial
    Triathlon CR/PS Inserts & ASYM Patella, Brunswik Captive Cemented Cup, Avon Patella Medium & Patella Femoral Joint, HMRS Humerus Bearing, MRH Bumper Neutral/3 Degrees & Tibial Inserts, Scorpio CR Tibial Insert & Medialised Patella, Duracon PCA Femoral, Patella & Constrain Inserts, Scorpio PS Tibial & Flex PS/+PS/+PCS Inserts (total knee, hip, shoulder components) and Artisan Bone PlugMultiple item and lot numbersARTG:128028, 139146, 128021, 128026, 139145, 145124, 128448, 141151 & 142278
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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