Events

Rappel de LFIT V40 Femoral Head

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-00129-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-02-24
  • 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-00129-1
  • 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 three customer complaints for a single lot of a specific size of the 32mm -4 v40 lfit vitallium femoral heads reporting that the femoral head could not be assembled with its corresponding v40 stem trunnion. upon investigation it was found that the female taper of the femoral head was not machined per drawing specifications, leaving a lip protruding approximately 0.007in from the taper surface at the inner base of the femoral head. this lip prevented the femoral head from successfully assembling with the associated male stem trunnion.No adverse consequences or delays to surgery were reported for any of the three complaints.
  • Action
    No additional patient follow-up or monitoring is required apart from usual routine follow-up, which will identify any issue. Symptomatic patients will present to their Health Care Practitioner. If any potential hazard or harms are detected by the Health Care Practitioner the appropriate action shall be taken. This action has been closed-out on 03/08/2016.

Device

LFIT V40 Femoral Head
  • Modèle / numéro de série
    LFIT V40 Femoral HeadCatalogue Number: 62609032Lot Number: 48681201ARTG Number: 211868
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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