Events

Rappel de Straumann dental surgical drills

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Straumann 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-2016-RN-01543-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-30
  • 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-01543-1
  • 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 investigation of a received complaint has confirmed that the shaft diameter of a drill article number 044.215 lot lv457 is greater than the defined specification of ø2.35mm in the area of the laser marking on the shaft. further investigation has shown that the further articles and lots are also impacted. testing with different handpieces shows that the drills can be inserted. however, depending on the manufacturing tolerances of the handpiece that is used, these drills may not fit. if the drills do not fit into the handpiece and there is not an alternative instrument available, then the the planned treatment would need to be re-scheduled.
  • Action
    Straumann has advised customers to check their inventory for affected product and return all stock. Straumann will provide replacements. This action has been closed-out on 09/06/2017.

Device

Straumann dental surgical drills
  • Modèle / numéro de série
    Straumann dental surgical drillsDrill 1, short, Ø 2.2mm, l 33.0mm, SSArticle #: 044.210 Lot #: MG783Component # Number (on drill): LZ239Twist Drill PRO Ø4.2mm,long,41mm,SSArticle #: 044.255 Lot #: LV455Component Lot # (on drill): LF828 ARTG Number: 119314
  • Manufacturer
    Straumann Pty Ltd

Manufacturer

Straumann Pty Ltd