Events

Rappel de Mako THA Application User Guides

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-01129-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-29
  • 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-01129-1
  • 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 identified that the tha application user guides for specific item numbers did not have the risk control measure included. five risk control measure were not included in the specific tha application user guides:1. user guide warning to indicate risk of greater trochanter fracture due to insertion of screw.2. user manual instruct no to re-capture check-point without re-registration of bone.3. statement in the user guide to unscrew the impaction handle from the implant cup prior to freeing the rio arm.4. training and user guide will indicate insertion of femoral checkpoint may weaken great trochanter. 5. end effector (item number 205020) provides sufficient clearance to mitigate the risk of impingement. standard or technique to visually confirm that cuposition is correct.
  • Action
    1. Inform users of this Recall for Product Correction and forward this notice to all those individuals who need to be aware within your organisation; 2. A Stryker representative will coordinate the swap out of the old version of the User Guides with the new version. The old version may continue to be used until the swap out has occurred; 3. Complete the supplied “Recall for Product Correction Notification Response” form upon receiving the letter to acknowledge you have seen it; and 4. Inform any recipients you may have transferred affected stock to.

Device

Mako THA Application User Guides
  • Modèle / numéro de série
    Mako THA Application User GuidesItem Numbers: 204863, 207116, 208692, 209711, 210555 and 212026All lots and versionsARTG Number: 223106
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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