Events

Rappel de Small Pedicle Probe ELL-IN 02 23-N

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Spineart Australia 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-00087-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-07
  • 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-00087-1
  • 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
    Spineart australia has been made aware that there is a non conformance on the graduation of the device. the graduation is 30/40/45/60 mm instead of 30/40/50/60 mm. investigation from the sponsor has determined that this engraving error comes from the etching step during manufacturing and had not been caught duing the manufacturers control step. no other batches of the same reference are affected by this issue.There have been no reported events as a reuslt of this issue.This action was undertaken prior to consultation with the therapeutic goods adminsitration (tga).
  • Action
    The affected item has been quarantined and returned to the manufacturer.

Device

Small Pedicle Probe ELL-IN 02 23-N
  • Modèle / numéro de série
    Small Pedicle Probe ELL-IN 02 23-NModel Reference Number: ELL-IN 02 23-NBatch Number: 3-8213ARTG Number: 228975
  • Manufacturer
    Spineart Australia Pty Ltd

Manufacturer

Spineart Australia Pty Ltd