Events

Rappel de MEDPOR Facial and Oculoplastic Sizer Sets and TLS Drain System

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-2017-RN-00052-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-11
  • 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-2017-RN-00052-1
  • 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
    A report has been received indicating that the outer label of a medpor sizer set states ‘sterile’, whereas the product is actually delivered non-sterile. investigations have revealed that additional products and lots have an incorrect sterility status on their labels. the introduction of a non-sterile device into the sterile surgery field could potentially cause infection requiring additional medical or surgical treatment.
  • Action
    Stryker is advising users to inspect their inventory and quarantine affected stock. They are requested to contact Stryker to coordinate the return of affected products for a resupply or a credit. This action has been closed out on 16 June 2017.

Device

MEDPOR Facial and Oculoplastic Sizer Sets and TLS Drain System
  • Modèle / numéro de série
    MEDPOR Facial and Oculoplastic Sizer Sets and TLS Drain SystemItem Numbers: 6630, 9951, 9952Multiple Lot NumbersARTG Numbers: 258033, 264273
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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