Events

Rappel de 3R62 Pheon Modular Knee Joint (External leg prosthesis)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Otto Bock 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-2016-RN-01512-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-11-22
  • 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-2016-RN-01512-1
  • 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
    It has been found that the locking function may fail under certain conditions. the activation locking can only be activated by the clinician prior to the fitting of the device. the units that have been supplied in australia do not have the locking mechanism activated. please note that when the locking mechanism is set as non-active, the device poses no safety risk to the patient. however, it is possible that in the course of time the patient’s physical condition may require the locking function to be activated.
  • Action
    Otto Back is advising clinicians to contact patients who have been fitted with the affected device for a replacement with the new version.

Device

3R62 Pheon Modular Knee Joint (External leg prosthesis)
  • Modèle / numéro de série
    3R62 Pheon Modular Knee Joint (External leg prosthesis)Serial Numbers: 201447012, 201512056, 201517011ARTG Number: 113606
  • Manufacturer
    Otto Bock Australia Pty Ltd

Manufacturer

Otto Bock Australia Pty Ltd