Events

Rappel de PILOT DRILL STAINLESS STEEL

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par STRAUMANN CANADA LIMITED.

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
    16421
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-11-28
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    The investigation of a complaint has confirmed that the shaft diameter of a drill (article 044.215 lot lv457) is greater than the defined specification of 2.35 mm in the area of the laser marking on the shaft. further investigation has shown that additional articles and lots are impacted. testing with different handpieces demonstrates that the drills can be inserted however depending on the manufacturing tolerances of the handpiece that is used these drills may not fit. the drills are multiple use instruments and are delivered non-sterile. in accordance with ifu 701124 they must be unpacked disinfected cleaned and sterilized before use. additionally the ifu states that "before every use the device has to be carefully checked for proper function and damage." if the drills do not fit into the handpiece and there is not an alternative instrument available then the planned treatment will need to be re-scheduled.

Device

PILOT DRILL STAINLESS STEEL
  • Modèle / numéro de série
    Model Catalog: 044.210 (Lot serial: LV457); Model Catalog: 044.214 (Lot serial: MH027); Model Catalog: 044.210 (Lot serial: MH027); Model Catalog: 044.215 (Lot serial: LV463); Model Catalog: 044.214 (Lot serial: LV463); Model Catalog: 044.210 (Lot serial: LV463); Model Catalog: 044.215 (Lot serial: LV457); Model Catalog: 044.214 (Lot serial: LV457); Model Catalog: 044.210 (Lot serial: MJ330); Model Catalog: 044.214 (Lot serial: MJ330); Model Catalog: 044.215 (Lot serial: MJ330); Model Catalog: 044.255 (Lot serial: LV455); Model Catalog: 044.215 (Lot serial: MH027)
  • Description du dispositif
    PILOT DRILL - STAINLESS STEEL;TWIST DRILL - STAINLESS STEEL
  • Manufacturer
    STRAUMANN CANADA LIMITED

Manufacturer

STRAUMANN CANADA LIMITED