Events

Rappel de CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone)

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-2016-RN-00484-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-22
  • 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-2016-RN-00484-1
  • 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
    The pivot cinchlock ss knotless anchor is a non-degradable implant device intended for the fixation of soft tissue to bone.Several complaints have been received relating to the pull wire breaking. there are two modes of failure identified for the pull wire; near the inserter handle and at the most distal tip where the wire ends with a larger diameter tip.The broken pull wire may spring out of the inserter handle that may injure the user. inserter components may break or disassemble leading to minor surgical delay to remove fragments or fragments left in bone after the procedure.
  • Action
    Stryker is advising users to inspect and quarantine any of the affected items. Affected stock can be returned to Stryker for replacement with unaffected stock. This action has been closed out 01 Feb 2017

Device

CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone)
  • Modèle / numéro de série
    CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone)Catalogue Number: CAT02462Lot Numbers: 15120801, 15121401, 16010402, 16011901, 16012501ARTG Number: 229717
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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