Events

Rappel de Polarstem Cardan for 21000438

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smith & Nephew 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-00927-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-07
  • 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-00927-1
  • 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
    Smith & nephew have identified a design issue for a specific model/batch of polarstem cardan for 21000438. the affected cardan joint could potentially fracture or functionally fail after multiple procedures. in the event the cardan breaks during use, the final implanted stem may have to be retrieved. this could potentially result in fragments of the broken components remaining in the wound.
  • Action
    Smith & Nephew is requesting Customers: 1. Immediately locate and quarantine affected devices; 2. If any of the recalled products could have been transferred from your hospital to another hospital please provide copies of the notice to all users informing them of the recall; 3. Please complete and sign and return the supplied Recall Acknowledgement Form with the number of affected devices you have to return, even if you have no products to return; 4. The acknowledgement form may be returned by email to RegulatoryAffairs.ANZ@smith-nephew.com or by fax on 1800 671 000 (Toll Free) 5. In the event customers have affected product to return, Smith & Nephew representatives will be in contact to arrange for affected products to be returned.

Device

Polarstem Cardan for 21000438
  • Modèle / numéro de série
    Polarstem Cardan for 21000438Model Number: 75102260Batch Number: A59547ARTG Number: 181339
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd