Events

Rappel de Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts during hip arthroplasty)

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-00808-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-15
  • 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-00808-1
  • 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
    During steam sterilisation validation with 3 half cycles (2 minutes, 132°c), it was identified that the trident constrained liner impactor tips do not meet the required sterility assurance level (sal) of 10-6.Please note that these instruments are sterilised at the hospital prior to surgery and are not distributed as sterile from stryker to customers. due to this inability to meet the sal, the instrument may be non-sterile and this could lead to a possible infection.
  • Action
    Stryker is advising users to inspect stock and quarantine any affected product for return. Stryker is providing information about alternative surgical methods of locking the insert into the shell. This action has been closed-out on 28/02/2018.

Device

Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts dur...
  • Modèle / numéro de série
    Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts during hip arthroplasty)Item Numbers: 21992022, 21992028, 21992032All Lot Numbers affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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