Events

Rappel de rHead Radial Head and Uni-Elbow 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-01347-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-30
  • 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-01347-1
  • 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 conducted a review of the currently available data of the stryker rhead radial head and uni-elbow system, and it was found to be inconclusive to continue supporting the performance of the device. the system is intended for replacement of the proximal end of the radius. this includes replacement of the radial head for degenerative or post-traumatic disabilities, presenting pain, crepitation and decreased motion at the radio humeral and/or proximal radio ulnar joint with joint destruction or subluxation visible on x-ray and resistance to conservative treatment.Post-operatively, the following may occur; implant loosening (septic and aseptic), instability (mod-severe), stress fracture (bone), cyst formation (bone resorption), stiffness, pain, impingement and heterotopic ossification.
  • Action
    Stryker is advising customers to inspect inventory for affected product and quarantine it immediately. Stryker will arrange collection of goods from affected sites. Health care professionals that have patients using the Stryker rHead Radial Head/Uni-Elbow Prosthesis System should continue to follow up those patients in accordance with the routine standard of care and be aware of this issue when doing so.

Device

rHead Radial Head and Uni-Elbow System
  • Modèle / numéro de série
    rHead Radial Head and Uni-Elbow SystemMultiple Item Numbers (see attached)All Lot NumbersARTG Numbers: 238712 (Stryker Australia Pty Ltd - Prosthesis, internal, joint, elbow, radial component)240014 (Stryker Australia Pty Ltd - Coated elbow humerus prosthesis)240015 (Stryker Australia Pty Ltd - Surgical procedure kit, orthopaedic, reusable)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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