Events

Rappel de AVS PL SPACER (Used as an aid in spinal fixation)

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-2014-RN-01131-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-10-23
  • 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-2014-RN-01131-1
  • 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 above catalogue numbers are specific to the us and supplied with the us labelling which has a different indication then those devices supplied outside of the us. specifically, the us versions indicated use with autogenous bone graft in patients with degenerative disc disease (ddd) at one level or two contiguous levels from l2 to s1. the australian indication does not include the limit to the contiguous levels or spinal region (l2-s1).
  • Action
    Stryker is requesting their customer to identify and return any affected stock. This action has been closed-out on 01/03/2016. This action has been closed-out on 01/03/2016.

Device

AVS PL SPACER (Used as an aid in spinal fixation)
  • Modèle / numéro de série
    AVS PL SPACER (Used as an aid in spinal fixation)AVS PL SPACER 7 X 20 X 4° 9MMCatalogue Number: 48340074Lot Numbers: 30646, 33494, 39184AVS PL SPACER 8 X 20 X 4° 9MMCatalogue Number: 48340084Lot Numbers: 33549, 38164, 38652, 39007, 39160AVS PL SPACER 7 X 25 X 4° 8MMCatalogue Number: 48345074Lot Number: 39188AVS PL SPACER 8 X 25 X 4° 8MMCatalogue Number: 48345084Lot Numbers: 39150, 38183ARTG Number: 178870
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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