Events

Rappel de D-Rad Titanium 2.4mm x 10mm Locking Screw T7 Self-Tapping

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-00925-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-09
  • 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-00925-1
  • 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 has identified that a number of devices are affected due to a labelling error. the expiration dates printed on the labels are incorrect; the dates shown are after the actual expiration date of the sterilised package.
  • 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 facility to another hospital, provide copies of this notice to all users informing them of the recall; 3.Complete,sign and return the supplied Recall Acknowledgement Form with the number of affected devices you have to return. Complete the form 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.If you have affected product to return, Smith & Nephew representatives will be in contact with you once you have returned the Acknowledgement Form to arrange for affected products to be returned. 6.New unaffected replacement devices will be provided to you once Smith & Nephew have received your response.

Device

D-Rad Titanium 2.4mm x 10mm Locking Screw T7 Self-Tapping
  • Modèle / numéro de série
    D-Rad Titanium 2.4mm x 10mm Locking Screw T7 Self-TappingModel Number: 74692412Batch Number: 15JM07539Expiry: September 2017ARTG Number: 104369
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd