Events

Rappel de Application Instrument for Sternal ZipFix

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Synthes 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-2013-RN-00924-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-09-03
  • 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-2013-RN-00924-1
  • 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 potential for zipfix implants to loosen if the implant is cut while the tensioning trigger is being squeezed. implants cut under tension can cause deformations in the teeth of the locking mechanism thereby compromising the integrity of the implants. the possibility exists for the zipfix implant to be compromised and loosen after implantation or during the post operative recovery period.
  • Action
    Customers are requested to contact their local Sales Consultant to arrange for replacement with a 2nd generation Application Instrument. DePuy Synthes has confirmed that all 1st generation applicators in loan sets will be replaced with 2nd generation applicators.

Device

Application Instrument for Sternal ZipFix
  • Modèle / numéro de série
    Application Instrument for Sternal ZipFixPart Number: 03.501.080Lot Number: All 1st generation Application Instruments - Lots prior to 8100630ARTG Number: 153950
  • Classification du dispositif
    Orthopedic Devices
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd