Events

Rappel de Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Cobalt Chrome (CoCrMo) sterile

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-00596-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-06-18
  • 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-00596-1
  • 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
    The manufacturer is recalling dls 3.7mm and 5.0mm following customer complaints of breakages at the distal tip of the pin after successful healing and during planned implant removal of the whole construct. no complaints have been reported by australian customers.
  • Action
    Customers are requested to quarantine all lots of the 3.7 mm and 5.0 mm Dynamic Locking Screws and contact a Depuy Synthes Trauma sales representative to organise the return of the affected devices. Depuy Synthes is also advising implanting surgeons of the appropriate follow up for patients implanted with the potentially affected Dynamic Locking Screw. For further details, please see http://www.tga.gov.au/safety/alerts-device-dynamic-130704.htm

Device

Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Co...
  • Modèle / numéro de série
    Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Cobalt Chrome (CoCrMo) sterileDynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm Cobalt-Chrome Alloy (CoCrMo) sterile, Part numbers: 09.213.22S, 09.213.070SDynamic Locking Screw Stardrive 5.0mm, self-tapping, length 32-90 mm, Cobalt Chrome (CoCrMo) sterilePart number: 09.223.032S, 09.223.090SAll lot numbers are affected
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd