Events

Rappel de SwiveLock SP Suture Anchor

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-00463-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-18
  • 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-00463-1
  • 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
    It has been determined that there is an issue with specific batches of the self-punching eyelet contained within the arthrex swivelock sp suture anchor which may cause the eyelet to break on insertion in hard bone.Please note that there is no impact to the patient if the device has been implanted successfully.
  • Action
    Device Technologies Australia (DTA) is requesting users to immediately discontinue use of the affected devices and to inform all relevant personnel at their facility of the recall notice. Users are further requested to quarantine their affected stock and return a completed Reply Fax Form, advising the quantity of affected stock. Users are advised that credit will be issued upon DTA's receipt of the returned items.

Device

SwiveLock SP Suture Anchor
  • Modèle / numéro de série
    SwiveLock SP Suture AnchorProduct Codes: AR-2323BSLM, AR-2323PSLM, AR-2324BCM, AR-2324PSLM, AR-2600SBS-5, AR-2600SBS-7Multiple Products and Batch NumbersARTG Numbers: 126657 and 164046
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd