Events

Rappel 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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical Pty Ltd T/A Depuy Australia.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00285-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2013-03-28
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00285-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    Updating the Instructions for Use (IFU)

Device

Blue Free Strand ORTHOCORD Sutures: Orthocord Blue without needles; Orthocord Blue & Violet witho...
  • Modèle / numéro de série
    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