Events

Rappel de GENESIS II FINNED STEM TIBIAL PUNCH

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

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
    16626
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2006-09-01
  • 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
    Punches were not manufactured to our specifications and the tip of the punch is welded on and not one piece as specified. this can cause the tip of the punch to break off during use.

Device

GENESIS II FINNED STEM TIBIAL PUNCH
  • Modèle / numéro de série
    Model Catalog: P/N 71434306 (Lot serial: EX. 00511384).); Model Catalog: P/N 71434304 (Lot serial: EX. 00511384).); Model Catalog: P/N 71434301 (Lot serial: ALL LOTS PRIOR TO); Model Catalog: P/N 71434302 (Lot serial: ALL LOTS PRIOR TO); Model Catalog: P/N 71434304 (Lot serial: ALL LOTS PRIOR TO); Model Catalog: P/N 71434306 (Lot serial: ALL LOTS PRIOR TO); Model Catalog: P/N 71434301 (Lot serial: 06MM***** SEQUENCE INCLUDING); Model Catalog: P/N 71434302 (Lot serial: 06MM***** SEQUENCE INCLUDING); Model Catalog: P/N 71434304 (Lot serial: 06MM***** SEQUENCE INCLUDING); Model Catalog: P/N 71434306 (Lot serial: 06MM***** SEQUENCE INCLUDING); Model Catalog: P/N 71434301 (Lot serial: THOSE ITEMS WITH SUFFIXES); Model Catalog: P/N 71434302 (Lot serial: THOSE ITEMS WITH SUFFIXES); Model Catalog: P/N 71434304 (Lot serial: THOSE ITEMS WITH SUFFIXES); Model Catalog: P/N 71434306 (Lot serial: THOSE ITEMS WITH SUFFIXES); Model Catalog: P/N 71434301 (Lot serial: (EX. 05LM03346B AND WITHOUT); Model Catalog: P/N 71434302
  • Description du dispositif
    GENESIS II nonporous tibial punch
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.