Events

Rappel de MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7

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-01493-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-12
  • 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-01493-1
  • 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 discovered that the packaging of certain sizes and lots of the above-referenced product may contain the incorrect product and/or label. two reports were received with the product/label discrepancy. in one report, the labelling of the implant box outer label stated size 2 rm/ll, and the labelling of the implant sticker (patient label) located inside the outer box state size 7 rm/ll. the correct implant size 2 rm/ll was inside the box. the patient label was incorrect in this report. the second report described that a size 2 implant was in a box labelled as a size 7 implant.
  • Action
    Stryker is advising users to quarantine affected stock immediately. Customers should contact their Stryker representative to arrange for return of affected product.

Device

MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7
  • Modèle / numéro de série
    MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7Item No: 180612; Lot No: 26080317-01Item No: 180617; Lot No: 26150217-01ARTG Number: 242173
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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