Events

Rappel de ACU-LOC 2 VOLAR DISTAL RADIUS PLATING SYSTEM - KICKSTAND POST

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
    20161
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-06-29
  • 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
    It has come to acumed's attention that five kickstand post batches and one drill guide batch have potentially nonconforming threads. this nonconformance would prevent the instruments from attaching to the plate. the inability to utilize these instruments could cause health hazards such as prolonged surgery or revision surgery.

Device

ACU-LOC 2 VOLAR DISTAL RADIUS PLATING SYSTEM - KICKSTAND POST
  • Modèle / numéro de série
    Model Catalog: 80-0718 (Lot serial: 397079); Model Catalog: 80-0718 (Lot serial: 397042); Model Catalog: 80-0731 (Lot serial: 397079); Model Catalog: 80-0722 (Lot serial: 397079); Model Catalog: 80-0720 (Lot serial: 397079); Model Catalog: 80-0731 (Lot serial: 397081); Model Catalog: 80-0722 (Lot serial: 397081); Model Catalog: 80-0720 (Lot serial: 397081); Model Catalog: 80-0718 (Lot serial: 397081); Model Catalog: 80-0731 (Lot serial: 397080); Model Catalog: 80-0722 (Lot serial: 397080); Model Catalog: 80-0720 (Lot serial: 397080); Model Catalog: 80-0718 (Lot serial: 397080); Model Catalog: 80-0731 (Lot serial: 403860); Model Catalog: 80-0722 (Lot serial: 403860); Model Catalog: 80-0720 (Lot serial: 403860); Model Catalog: 80-0718 (Lot serial: 403860); Model Catalog: 80-0731 (Lot serial: 397042); Model Catalog: 80-0722 (Lot serial: 397042); Model Catalog: 80-0720 (Lot serial: 397042); Model Catalog: 80-0384 (Lot serial: 402434)
  • Description du dispositif
    ACU-LOC 2 VOLAR DISTAL RADIUS PLATING SYSTEM - KICKSTAND POST;LOWER EXTREMITY CONGRUENT PLATING SYSTEM - LOCKING DRILL GUIDE
  • Manufacturer
    CONMED CANADA

Manufacturer

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