Events

Rappel de Safety Clip - Hoffmann Limb Reconstruction Frame (LRF) Bone Transport

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker 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-2017-RN-00531-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-27
  • 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-2017-RN-00531-1
  • 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
    Stryker has found that there is the potential for loosening of the safety clips from the intended position on the quick release mechanism of the transport struts. in the case of no safety clip and/or overloading, the frame may loosen, bend or break in time, causing frame stability collapse.
  • Action
    Stryker is advising customers to immediately inspect inventory and quarantine affected product. Stryker will coordinate return of the product and provide credit. Clinicians are advised to inspect if the Safety Clips are still in place when patients come in for routine follow up examination and replace the Safety Clips, and to consider contacting patients that do not show up for routine follow up examination. The need to replace the entire Hoffmann LRF Bone Transport if indicated should also be considered.

Device

Safety Clip - Hoffmann Limb Reconstruction Frame (LRF) Bone Transport
  • Modèle / numéro de série
    Safety Clip - Hoffmann Limb Reconstruction Frame (LRF) Bone TransportItem Number: 49330401 Lot Numbers: J49236, V07241, V30655, V47575, V49404 ARTG Number: 258035
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA