Events

Rappel de PyroTitan Humeral Resurfacing Arthroplasty Shapers

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par LMT Surgical 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-00091-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-28
  • 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-00091-1
  • 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
    It has been determined that certain affected lots of non-conforming product may not be as sharp as intended by design.This may be evident during use by having to increase the applied force to the shaper needed to cut and form the humeral head effectively for the placement of the implant. this increase in force can in-turn, which could create undesirable friction between the shaper and the humeral head that could potentially result in bone tissue being burned.
  • Action
    Integra LifeSciences is advising users that affected stock can be used if there are no alternatives available. Affected stock will be replaced with unaffected units.

Device

PyroTitan Humeral Resurfacing Arthroplasty Shapers
  • Modèle / numéro de série
    PyroTitan Humeral Resurfacing Arthroplasty ShapersMultiple Catalogue and Lot Numbers affectedARTG Number: 111050
  • Manufacturer
    LMT Surgical Pty Ltd

Manufacturer

LMT Surgical Pty Ltd