Events

Rappel de COLLINS RADIOPARENT STERNAL BLADES

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

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
    120619
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-04-09
  • 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 recall has been initiated due to an issue with the device breaking during surgical procedures where the sternum needs to be retracted. the device is breaking where the retractor blade assembles to the stainless steel retractor body. the device is not breaking where it comes in contact with the patient. use of this device may cause a risk to the patient and hospital staff if the device breaks at the retractor blade and retractor body connection point this could prolong the surgery.

Device

COLLINS RADIOPARENT STERNAL BLADES
  • Modèle / numéro de série
    Model Catalog: 50-8081 (Lot serial: 296160); Model Catalog: 50-8081 (Lot serial: 244576); Model Catalog: 50-8081 (Lot serial: 296156); Model Catalog: 50-8081 (Lot serial: 296155); Model Catalog: 50-8081 (Lot serial: 296153); Model Catalog: 50-8081 (Lot serial: 296141); Model Catalog: 50-8081 (Lot serial: 296139); Model Catalog: 50-8081 (Lot serial: 296136); Model Catalog: 50-8081 (Lot serial: 276514); Model Catalog: 50-8081 (Lot serial: 276513); Model Catalog: 50-8081 (Lot serial: 268920); Model Catalog: 50-8081 (Lot serial: 268916); Model Catalog: 50-8081 (Lot serial: 244584); Model Catalog: 50-8081 (Lot serial: 244582); Model Catalog: 50-8081 (Lot serial: 296157)
  • Description du dispositif
    Collins Radioparent Sternal Blades Nylon 4 3/4" Long 3" Wide 1 1/2" Deep
  • Manufacturer
    SYMMETRY SURGICAL

Manufacturer

SYMMETRY SURGICAL