Events

Retiro De Equipo (Recall) de D-Rad Titanium 2.4mm x 10mm Locking Screw T7 Self-Tapping

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-00925-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-09
  • 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-00925-1
  • 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 has identified that a number of devices are affected due to a labelling error. the expiration dates printed on the labels are incorrect; the dates shown are after the actual expiration date of the sterilised package.
  • 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 facility to another hospital, provide copies of this notice to all users informing them of the recall; 3.Complete,sign and return the supplied Recall Acknowledgement Form with the number of affected devices you have to return. Complete the form 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.If you have affected product to return, Smith & Nephew representatives will be in contact with you once you have returned the Acknowledgement Form to arrange for affected products to be returned. 6.New unaffected replacement devices will be provided to you once Smith & Nephew have received your response.

Device

D-Rad Titanium 2.4mm x 10mm Locking Screw T7 Self-Tapping
  • Modelo / Serial
    D-Rad Titanium 2.4mm x 10mm Locking Screw T7 Self-TappingModel Number: 74692412Batch Number: 15JM07539Expiry: September 2017ARTG Number: 104369
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd