Events

Retiro De Equipo (Recall) de Twinfix Ultra Ti Suture Anchor, 5.5mm (used to attach the end or ends of a synthetic or natural ligament to bone)

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 Surgical 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-00678-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-05
  • 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-00678-3
  • 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
    The manufacturer has advised that the distal part of the anchor may break on insertion into bone during surgery. the surgery may be completed using an alternative fixation device and, in most cases, the broken anchor can be retrieved with a grasper or sharp instrument.
  • Acción
    Quarantine and return affected stock to Smith & Nephew Surgical for replacement.

Device

Twinfix Ultra Ti Suture Anchor, 5.5mm (used to attach the end or ends of a synthetic or natural l...
  • Modelo / Serial
    Twinfix Ultra Ti Suture Anchor, 5.5mm (used to attach the end or ends of a synthetic or natural ligament to bone)Catalogue Numbers: 72202618 & 72202895Multiple lot numbersARTG Number: 109451
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd