Events

Rappel de PCA Tapers, LFIT V40 Tapers, V40 Tapers (Vitallium Femoral Heads)

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-2015-RN-00922-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-01
  • 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-2015-RN-00922-1
  • 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 has received four customer complaints for lfit v40 vitallium femoral heads (manufactured july 7th 2014 – august 15th 2014) reporting that the femoral head could not be assembled with its corresponding v40 stem trunnion at the time of surgery. upon investigation it was found that the female v40 taper of the four complaint devices were not machined per drawing specifications, leaving a lip protruding from the taper surface at the inner base of the femoral head. this lip prevented the femoral head from successfully locking with the associated male stem trunnion. in each case a new v40 lfit vitallium femoral head was opened and used. no other adverse consequences or delays to surgery were reported for any of these complaints.
  • Action
    Stryker is advising users to inspect stock and quarantine any affected devices. Stryker will replace any affected devices with unaffected devices. A femoral head that has not achieved a taper lock will be clearly evident during verification, thus reducing the occurrence of the implantation of an unlocked femoral head.

Device

PCA Tapers, LFIT V40 Tapers, V40 Tapers (Vitallium Femoral Heads)
  • Modèle / numéro de série
    PCA Tapers, LFIT V40 Tapers, V40 Tapers (Vitallium Femoral Heads)Multiple catalogue numbers affectedMultiple lot numbers affectedARTG Numbers: 211858, 211868, 211869
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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