Events

Rappel de SYNTHES (USA)MODULAR BLADE PLATE SYSTEM- 100MM SPIRAL BLADE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SYNTHES (CANADA) 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
    103909
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-10-22
  • 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
    Synthes is initiating a recall on all lots of the synthes spiral blade associated with the modular blade plate system due to a potential for an out of specification star grind teeth of the spiral plate. the potential of insufficient depth of the spiral blade star grind teeth could lead to loosening of the coupling screw. this may present a potential risk to the patient including loss of reduction construct failure and need for additional surgical intervention.

Device

SYNTHES (USA)MODULAR BLADE PLATE SYSTEM- 100MM SPIRAL BLADE
  • Modèle / numéro de série
    Model Catalog: 02.122.600 (Lot serial: ALL LOTS); Model Catalog: 02.122.601 (Lot serial: ALL LOTS); Model Catalog: 02.122.571 (Lot serial: ALL LOTS); Model Catalog: 02.122.586 (Lot serial: ALL LOTS); Model Catalog: 02.122.606 (Lot serial: ALL LOTS); Model Catalog: 02.122.605 (Lot serial: ALL LOTS); Model Catalog: 02.122.585 (Lot serial: ALL LOTS); Model Catalog: 02.122.570 (Lot serial: ALL LOTS); Model Catalog: 02.122.551 (Lot serial: ALL LOTS); Model Catalog: 02.122.615 (Lot serial: ALL LOTS); Model Catalog: 02.122.580 (Lot serial: ALL LOTS); Model Catalog: 02.122.581 (Lot serial: ALL LOTS); Model Catalog: 02.122.616 (Lot serial: ALL LOTS); Model Catalog: 02.122.575 (Lot serial: ALL LOTS); Model Catalog: 02.122.576 (Lot serial: ALL LOTS); Model Catalog: 02.122.620 (Lot serial: ALL LOTS); Model Catalog: 02.122.621 (Lot serial: ALL LOTS); Model Catalog: 02.122.565 (Lot serial: ALL LOTS); Model Catalog: 02.122.561 (Lot serial: ALL LOTS); Model Catalog: 02.122.560 (Lot serial: ALL LOTS); Model Catalog: 02.122.5
  • Description du dispositif
    SYNTHES MODULAR BLADE PLATE SYSTEM 100MM SPIRAL BLADE
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    HC