Events

Rappel de Thin and Radial Osteotome Blades Multiple Products and Model Numbers

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-00872-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-19
  • 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-00872-1
  • 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 a labelling error with specific models and batches of thin and radial osteotome blades. the expiration dates on the label exceed the actual validated expiration date of the outer sterile barrier packaging. affected devices have expiration dates based on a 10 year packaging shelf-life where the actual validated shelf life of the outer pouch packaging is 5 years. this could potentially result in the outside of the inner tray packaging being non-sterile, potentially contaminating the sterile field.The inner tray packaging is validated for a 10 year shelf-life and to date no adverse events have been associated with this issue.
  • 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 their hospital to another hospital please provide copies of the recall notice to all users; 3. The supplied acknowledgement form may be returned by email to RegulatoryAffairs.ANZ@smith-nephew.com or by fax on 1800 671 000 (Toll Free) 4. If you have affected product to return, Smith & Nephew representatives will be in contact with customers once the Recall Acknowledgement Form has been received to arrange for affected products to be returned. Please keep a copy of the completed Recall Acknowledgement form with any affected stock to be returned; and 5. Replacement products will be arranged once Smith & Nephew receive the Recall Acknowledgement Form.

Device

Thin and Radial Osteotome Blades Multiple Products and Model Numbers
  • Modèle / numéro de série
    Thin and Radial Osteotome Blades Multiple Products and Model NumbersMultiple Batch NumbersARTG Number: 140704
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd