Events

Rappel de Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants)

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-00554-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-26
  • 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-00554-1
  • 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
    There is a potential that the packaging integrity (sterile barrier) of the packaging type kit i may be compromised by transportation. a compromised sterile barrier could result in the surgeon selecting a back-up device or, if not recognised, an unintended implantation of a potentially non sterile device. the packaging type kit i consists of a white cardboard box, an outer peel pouch, and an inner peel pouch.
  • Action
    Stryker is notifying hospitals and surgeons of the issue and recovering stock supplied to hospitals. Surgeons are advised of the potential hazards involved in the implantation of devices where the sterile barrier has been breached. This action has been closed-out on 18/08/2016.

Device

Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants)
  • Modèle / numéro de série
    Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants)rHead Recon Stem Implant non-coated:Size 1 Item: RCNS160, Lot: 19804S2Size 2 Item: RCNS260, Lot: 19773-S2Size 3 Item: RCNS360, Lot: 19807S2Bipolar stem implant #1 Item RCNS1, Lot 19716S2Bipolar stem implant #3 Item RCNS3, Lot19720-S2Bipolar stem implant #4 Item RCNS4, Lot19816-S2Radial stem implant #1 Item RHAS1, Lot19778S2 Radial stem implant #4 Item RHAS4, Lot19814-S2
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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