Events

Rappel de ADM/MDM Ball Impactor Tip and ADM Rim Impactor Tip (reusable surgical instrument used to implant Stryker's Automatic Dual Mobility (ADM) and/or the Modular Dual Mobility (MDM) Acetabular Systems)

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-2013-RN-01033-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-04
  • 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-2013-RN-01033-1
  • 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 received complaints associated with cracks and/or fractures of the ball impactor tip and rim impactor tip instruments. the potential hazards include;- cracked or fractured ball impactor tip/rim impactor tip- loose fragments form the ball impactor tip/rim impactor tip- insufficient locking strength of the mdm liner (ball impactor tip only).
  • Action
    Stryker is releasing updated surgical procedures and also updating the loan dockets, recommending the use of a slotted mallet to be used to impact the impactor handle, and emphasising that all tips should be inspected for deformation and cracks before use.

Device

ADM/MDM Ball Impactor Tip and ADM Rim Impactor Tip (reusable surgical instrument used to implant ...
  • Modèle / numéro de série
    ADM/MDM Ball Impactor Tip and ADM Rim Impactor Tip (reusable surgical instrument used to implant Stryker's Automatic Dual Mobility (ADM) and/or the Modular Dual Mobility (MDM) Acetabular Systems)ADM/MDM Ball Impactor TipCatalogue Numbers: 12350013 (12350303A-T, 12350306-T, 12350306V-T, 12350306C-T) ADM Rim Impactor TipCatalogue Numbers: 12350014 (12350303A-T)All Lot Numbers AffectedARTG Number: 181721
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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