Events

Rappel de METS Principal Shaft

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-01412-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-13
  • 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-01412-1
  • 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 initiated a lot specific hazard alert. the mets product family of components are double pouched in polyamide/polyethylene (pa/pe) material and a box. during inspection, certain mets principal shafts were found to be missing the outer pouch. upon review, two additional principal shafts from the same lot were also discovered to be missing an outer pouch.
  • Action
    Patients implanted with an affected lot number of the METS Principal Shaft should continue to be followed per the normal protocol established by his/her surgeon. Inform users of this Hazard Alert and forward this notice to all those individuals who need to be aware within your organisation. Complete the “Hazard Alert Notification Response” form, and return the form to Stryker electronically by email as directed.

Device

METS Principal Shaft
  • Modèle / numéro de série
    METS Principal ShaftItem Number - msfshaft/150Lot Number - B10562ARTG Number: 246516 (Stryker Australia Pty Ltd - Femur/tibia shaft prosthesis)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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