Events

Retiro De Equipo (Recall) de nanOss Bioactive 10cc Bone Void Filler

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por RTI Surgical 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-2017-RN-01005-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-08-10
  • 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-01005-1
  • 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
    Rti surgical has been advised that a specific batch of nanoss bioactive 10cc bone void filler was shipped at the incorrect revision.Although the revision of the product as a whole (implant, accessories, packaging, labelling) was rev a instead of rev b, the implant itself remained unchanged and is safe. the changes included removal of an accessory syringe provided for rehydration, and minor changes to the labelling and ifu. no changes between revisions impact patient safety.To date, there have been zero complaints, as this issue was found internally only.
  • Acción
    RTI Surgical is requesting customers inspect their stocks and quarantine all units from the affected batch number. Complete the supplied Customer Acknowledgement Form and return it via email to RTI Surgical so that they may arrange for your stock to be recovered and for replacement stock, or a credit note to be issued. Complete the supplied Customer Acknowledgement Form even if you have no stock which is subject to this recall action as RTI Surgical requires this information to reconcile this process.

Device

nanOss Bioactive 10cc Bone Void Filler
  • Modelo / Serial
    nanOss Bioactive 10cc Bone Void FillerCatalogue Number: 90-100-10ELot Number: 257592Expiry: 10/03/2018ARTG Number: 279230
  • Manufacturer
    RTI Surgical Australia Pty Ltd

Manufacturer

RTI Surgical Australia Pty Ltd
  • Source
    DHTGA