Events

Rappel de SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary reaming system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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-01520-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-21
  • 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-01520-1
  • 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
    There is the potential that the affected lot of the synream flexible shaft may have been manufactured with a non-symmetric hexagonal coupling which may result in the reamer shaft not fitting into the reamer heads. in the event that the flexible shaft cannot be assembled with the reamer head, surgical delay may occur if another device is not available in the surgical suite.
  • Action
    JJM is advising customers to immediately quarantine affected product, and then contact JJM who will arrange for return of the product and replacement. This action has been closed-out on 11/05/2017.

Device

SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary r...
  • Modèle / numéro de série
    SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary reaming system)Part Number: 352.040Lot Number: 9946822The SynReam Flexible Shaft may be contained within the following two kitsLS SynReamKit Number: ZXAUTR1671 Equipment Number: 3000072587 SynReam Kit Number: ZXAUTR2316Equipment Number: 3000108391ARTG Number: 153666
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes