Events

Rappel de NAJA Spinal Ligament Systems for Spinal Stabilization

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Evolution Surgical Pty Ltd.

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-2018-RN-00007-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-10
  • 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-2018-RN-00007-1
  • 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
    The manufacturer, cousin biotech, through post-market surveillance systems has identified three successive cases of breakage of the metal connector clamping system that occurred during surgery. for these three incidents, there were no serious clinical outcomes for patients except a slight increase in operating time to use another medical device.
  • Action
    1. The letter should be passed on to end-users, to all persons concerned in your company, or to any other organization (healthcare centers) to which potentially affected products have been sent. 2. Check stock and quarantine all unused devices with the batch numbers identified. 3. Complete the supplied form and return it to the email address provided for the sponsor to arrange the collection of affected units.

Device

NAJA Spinal Ligament Systems for Spinal Stabilization
  • Modèle / numéro de série
    NAJA Spinal Ligament Systems for Spinal StabilizationReference Numbers: RCBNAJ55LU, RCBNAJ55RUBatch Numbers - 141527, 141724, 141896, 151605, 151940, 151939, 152079, 152319, 171823, 170696, 172044, 151604, 152080ARTG Number: 273278 (Evolution Surgical Pty Ltd - Spinal internal fixation system, intervertebral body)
  • Manufacturer
    Evolution Surgical Pty Ltd

Manufacturer

Evolution Surgical Pty Ltd
  • Source
    DHTGA