Events

Rappel de T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Synthes 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-2014-RN-00852-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-07-31
  • 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-2014-RN-00852-1
  • 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’s assessment has identified that incorrect handling of the t-pal applicator instrument could potentially contribute to failure of the applicator inner shaft (pn 03.812.003) during insertion of implants or the non-detachable t-pal trial implants (pn 03.812.307-.317 and 03.812.507-517). as a result, the t-pal technique guide (pn 036.001.088) was updated to clarify instrument handling of the t-pal applicator (pn 03.812.001 applicator outer shaft, pn 03.812.004 applicator knob). if the inner shaft should break, the trial (or implant) spacer will no longer be secured in the 0° position. this rigid position is necessary for insertion. if the inner shaft should break in the pivoting position, the assembly cannot be properly advanced into the disc space.
  • Action
    Synthes Australia is requesting their customers to replace the T-PAL Technique Guide with the updated version (PN 036.001.088, Version AD). This action has been closed-out on 03/06/2016.

Device

T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System)
  • Modèle / numéro de série
    T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System) ARTG number: 153950
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd