Events

Retiro De Equipo (Recall) de Blue Free Strand ORTHOCORD Sutures: Orthocord Blue without needles; Orthocord Blue & Violet without needles; Orthocord Blue & Violet with needles; Orthocord Violet/Blue W/ MO 06 NDLE PK12; Orthocord Violet/Blue W/ OS 06 NDLE PK12 (Sutures used in general soft Tissue approximation and or ligation, including orthopeadic procedures

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd T/A Depuy Australia.

¿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-2013-RN-00285-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-03-28
  • 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-2013-RN-00285-1
  • 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
    There is an update to the instructions for use (ifu) to reflect that blue free strand orthocord® sutures are expected to retain 80% of their original strength at six weeks after implantation, instead of 100% as indicated in the current ifu.
  • Acción
    Updating the Instructions for Use (IFU)

Device

Blue Free Strand ORTHOCORD Sutures: Orthocord Blue without needles; Orthocord Blue & Violet witho...
  • Modelo / Serial
    Blue Free Strand ORTHOCORD Sutures: Orthocord Blue without needles; Orthocord Blue & Violet without needles; Orthocord Blue & Violet with needles; Orthocord Violet/Blue W/ MO 06 NDLE PK12; Orthocord Violet/Blue W/ OS 06 NDLE PK12 (Sutures used in general soft Tissue approximation and or ligation, including orthopeadic proceduresProduct codes: 223111, 223113, 223114, 223115 & 223116ARTG Numbers: 121837 & 121836
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia