Events

Rappel de Signature Orthopaedics Logival 20 degree Hooded XLPE Liner (Hip Replacement Prosthesis, Acetabular Component)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Signature Orthopaedics 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-01413-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-11-15
  • 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-01413-1
  • 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
    Signature orthopaedics is recalling the affected batches of the logical 20 degree hooded xlpe liner. the batch numbers are displayed on the product labels. these devices are not intended for the market in australia, and had been distributed following a logistical error.There is no risk to patient safety as a result of this issue.
  • Action
    Signature Orthopaedics is advising users to inspect stock and quarantine any remaining units from the affected batches. There is no additional safety risks or follow up required for implanted devices.

Device

Signature Orthopaedics Logival 20 degree Hooded XLPE Liner (Hip Replacement Prosthesis, Acetabula...
  • Modèle / numéro de série
    Signature Orthopaedics Logival 20 degree Hooded XLPE Liner (Hip Replacement Prosthesis, Acetabular Component) Catalogue Numbers: 111-12-0250, 111-12-0660, 111-12-0652, 111-12-0656Batch Numbers: 77FAE, 78320, 78347, 7739B, 78334, 7739C-1ARTG Number: 277875 (Signature Orthopaedics Pty Ltd - Logical XLPE Liner - Non-constrained polyethylene acetabular liner)
  • Manufacturer
    Signature Orthopaedics Pty Ltd

Manufacturer

Signature Orthopaedics Pty Ltd