Events

Rappel de STERLING BURRS AND ROUTER

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

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
    55207
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-12-21
  • 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
    This recall has been initiated due to an assembly error caused by the inadvertent mixing of two sizes of bearings which occurred on the manufacturing line. conmed received 10 complaints of metal shavings coming from the burs during use due to contact between the bur and the hood of the prebent bur assembly. this could potentially render the device inoperable and could potentially cause a minor injury to the patient if the metal debris drops into the patient operative site. in no instance has it been reported to conmed corporation that this issue has resulted in illness or injury. all lots codes of catalog no. hps-hb11 hps-hb12 and hps-hb13 (hip preservation system signature series prebent burs) manufactured from june 18 2014 through to october 2 2015 are being removed from the market by this recall action.

Device

STERLING BURRS AND ROUTER
  • Modèle / numéro de série
    Model Catalog: HPS-HB11 (Lot serial: ALL LOTS); Model Catalog: HPS-HB13 (Lot serial: ALL LOTS)
  • Description du dispositif
    PREBENT BURS
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    CONMED Corp.
  • Source
    HC