Events

Rappel de Attachment for Acetabular and Medullary Reaming (used with the Compact Air Drive II, an air-driven power tool for use in traumatology, endoprosthetics and spinal column surgery)

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 Synthes.

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-2015-RN-01094-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-11-10
  • 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-2015-RN-01094-1
  • 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 geometrical shape of a subcomponent of this attachment was inadvertently changed. this change allows potential unintended reverse (counter-clockwise) motion if the subcomponent is aligned in a specific orientation when the attachment is connected to the handpiece and both triggers are pressed.This attachment is intended to be used without reverse motion. unintentional activation in reverse could potentially damage flexible drilling or reaming shafts and could potentially cause serious injury to the patient.
  • Action
    Customer to return affected product. Sponsor to replace affected product. This action has been closed-out on 24/08/2016.

Device

Attachment for Acetabular and Medullary Reaming (used with the Compact Air Drive II, an air-drive...
  • Modèle / numéro de série
    Attachment for Acetabular and Medullary Reaming (used with the Compact Air Drive II, an air-driven power tool for use in traumatology, endoprosthetics and spinal column surgery)Product Number 511.785Serial Numbers: 16384,16385,16386,16387,16389,16390,16391,16392,16393, 16394,16395,16396,16397,16403,16405,1641ARTG Number: 157072
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes