Events

Rappel de SynReam Reaming Rod 2.5mm, L 650mm, sterile(re-usable surgical instrument supplied as part of the SynReam Reaming 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-01372-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-20
  • 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-01372-1
  • 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
    An issue has been identified where peel pouches for certain lot numbers of reaming rods are de-laminating. this may lead to surgical staff members experiencing difficulty in opening the peel pouches and potentially causing the sterile device to come in contact with a non-sterile layer of the pouch.In the event there is difficulty in opening the sterile peel pouch a surgical delay may occur while a replacement part is located or while re-sterilisation is performed. if surgery cannot be completed without the sterile part and no alternate is available, the procedure may need to be rescheduled. if there is delamination of the peel pouches the layering and fragments may compromise the sterility of the part, which may place the patient at risk for infection.
  • Action
    Johnson & Johnson is advising customers to immediately quarantine affected product. Affected product may then be returned to Johnson & Johnson for replacement or unopened affected product may be re-sterilised per the product Sterilisation Instructions contained within the Instructions for Use provided with the product.

Device

SynReam Reaming Rod 2.5mm, L 650mm, sterile(re-usable surgical instrument supplied as part of the...
  • Modèle / numéro de série
    SynReam Reaming Rod 2.5mm, L 650mm, sterile(re-usable surgical instrument supplied as part of the SynReam Reaming medullary reaming system)Part Number: 351.709SLot Numbers: 9913259, 9913260, 9963747, 9963748, 9963749, 9963751, 9963752, 9963753, 9963755, 9963756, 9963757, H040517, H040518, H060114, H060115, H060116, H080081, H080082, H080083, H080084, H080085, H080086, H080087, H080088, H080089, H105530ARTG Number: 15395
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes