Events

Rappel de REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-impaired users to provide enhanced functional mobility for exercise and rehabilitation purposes)

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

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-00852-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-01
  • 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-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
    Rex bionics has been made aware of a patient injury, relating to incorrectly securing the heel stops on the rex. the patient suffered bilateral upper and lower tibial and bilateral lower fibular fractures following a spasm which resulted in unsecured heel stops moving backwards. the injuries may have been exacerbated by the use of ankle foot orthoses (afo) which restricted the users’s range of motion greater than required by rex.The heel stop must be correctly aligned with the measurement on the footplate corresponding to the user’s ankle to hind-foot measurement. once adjusted, the heel stop must be secured by tightening the locking nut. failure to do this may cause the user’s leg to move out of alignment, which may result in serious injury.
  • Action
    Rex Bionics is advising users of the importance of the correct heel stop adjustment, and securing using the tightening of the locking nut. Revised Instructions for Use (IFU) will be provided regarding the heel stops and the use of Ankle Foot Orthoses which limit the range of motion for a patient. This action has been closed out on 16 June 2017.

Device

REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-...
  • Modèle / numéro de série
    REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-impaired users to provide enhanced functional mobility for exercise and rehabilitation purposes) All devices affectedARTG Numbers: 237572, 271519
  • Manufacturer
    Rex Bionics Australia Pty

Manufacturer

Rex Bionics Australia Pty
  • Source
    DHTGA