Events

Retiro De Equipo (Recall) de Thin and Radial Osteotome Blades Multiple Products and Model Numbers

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-00872-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-19
  • 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-00872-1
  • 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 a labelling error with specific models and batches of thin and radial osteotome blades. the expiration dates on the label exceed the actual validated expiration date of the outer sterile barrier packaging. affected devices have expiration dates based on a 10 year packaging shelf-life where the actual validated shelf life of the outer pouch packaging is 5 years. this could potentially result in the outside of the inner tray packaging being non-sterile, potentially contaminating the sterile field.The inner tray packaging is validated for a 10 year shelf-life and to date no adverse events have been associated with this issue.
  • 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 their hospital to another hospital please provide copies of the recall notice to all users; 3. The supplied acknowledgement form may be returned by email to RegulatoryAffairs.ANZ@smith-nephew.com or by fax on 1800 671 000 (Toll Free) 4. If you have affected product to return, Smith & Nephew representatives will be in contact with customers once the Recall Acknowledgement Form has been received to arrange for affected products to be returned. Please keep a copy of the completed Recall Acknowledgement form with any affected stock to be returned; and 5. Replacement products will be arranged once Smith & Nephew receive the Recall Acknowledgement Form.

Device

Thin and Radial Osteotome Blades Multiple Products and Model Numbers
  • Modelo / Serial
    Thin and Radial Osteotome Blades Multiple Products and Model NumbersMultiple Batch NumbersARTG Number: 140704
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd