Events

Retiro De Equipo (Recall) de Polarstem Cardan for 21000438

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew 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-2017-RN-00927-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-07
  • 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-2017-RN-00927-1
  • 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
    Smith & nephew have identified a design issue for a specific model/batch of polarstem cardan for 21000438. the affected cardan joint could potentially fracture or functionally fail after multiple procedures. in the event the cardan breaks during use, the final implanted stem may have to be retrieved. this could potentially result in fragments of the broken components remaining in the wound.
  • Acción
    Smith & Nephew is requesting Customers: 1. Immediately locate and quarantine affected devices; 2. If any of the recalled products could have been transferred from your hospital to another hospital please provide copies of the notice to all users informing them of the recall; 3. Please complete and sign and return the supplied Recall Acknowledgement Form with the number of affected devices you have to return, even if you have no products to return; 4. The acknowledgement form may be returned by email to RegulatoryAffairs.ANZ@smith-nephew.com or by fax on 1800 671 000 (Toll Free) 5. In the event customers have affected product to return, Smith & Nephew representatives will be in contact to arrange for affected products to be returned.

Device

Polarstem Cardan for 21000438
  • Modelo / Serial
    Polarstem Cardan for 21000438Model Number: 75102260Batch Number: A59547ARTG Number: 181339
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd