Events

Rappel de Scorpio Patella Clamp (used to hold the patella in place during the cementing process)

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-2016-RN-01063-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-10
  • 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-2016-RN-01063-1
  • 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 orthopaedics has received four reports of disassociated components of the scorpio patella clamp. an investigation revealed that the press-fit specifications between the pins and either one or both clamping subcomponents were not met. no adverse patient consequences were reported. the instrument components, including pins and clamping subcomponents may potentially disassociate and fall into the wound intra-operatively, necessitating retrieval. as such, the potential harms may include: - complications associated with extended surgery time - inflammatory response - tissue damage - revision surgery to retrieve loose components.
  • Action
    Stryker is advising users to inspect stock and quarantine the whole tray immediately if the affected product is found. A Stryker representative will coordinate a replacement clamp or the return of the whole tray that the affected item is in and provide access to unaffected trays as required. This action has been closed-out on 18/05/2017.

Device

Scorpio Patella Clamp (used to hold the patella in place during the cementing process)
  • Modèle / numéro de série
    Scorpio Patella Clamp (used to hold the patella in place during the cementing process)Item Number: 3182-1000Tray Item Numbers: 31821000-T, 33023024-T, 80002017-T, 80106661-T, 8200TSX-TMultiple Lot Numbers affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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