Events

Rappel de Aequalis Reversed II and Reversed Fracture Impactors (supplied as part of Aequalis Reversed II and Reversed Fracture Instrument sets, YKAD83 &YKAD95;)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Tornier 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-2013-RN-01035-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-23
  • 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-2013-RN-01035-1
  • 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
    Following the identification of the disassociation of an impactor tip during a surgery, without any clinical consequences for the patient, tornier has initiated recall of all lots of aequalis reversed ii and reversed fracture impactors (items number mwd021, mwd023, mwd024, mwd025). upon review of the event, tornier determined that a redesign of the instrumentation was warranted.This recall action was carried out prior to approval by the therapeutic goods administration.
  • Action
    In the interim the manufacturer (Tornier SAS) has recommended an alternative method using other impactors that are available in other Tornier shoulder instrument sets. Tornier has issued a specific operative technique to explain which impactor to be used. The replacement with new impactors has begun.

Device

Aequalis Reversed II and Reversed Fracture Impactors (supplied as part of Aequalis Reversed II an...
  • Modèle / numéro de série
    Aequalis Reversed II and Reversed Fracture Impactors (supplied as part of Aequalis Reversed II and Reversed Fracture Instrument sets, YKAD83 &YKAD95;)Aequalis Reversed II Insert Impaction HandleItem Number: MWD021Aequalis Reversed II Insert Impactor TipItem Number: MWD023Hemiprosthesis Adaptor Impactor TipItem Number: MWD024Aequalis Reversed II Anatomic Head Impactor TipItem Number: MWD024ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd