Events

Rappel de GRAPHIC CASES FOR 6.5MM & 7.3MM CANNULATED SCREW SETS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    94209
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2018-03-08
  • 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
    Depuy synthes is conducting a lot-specific recall of the graphic cases for 6.5mm and 7.3mm cannulated screw sets because they contain screw gauges that incorrectly measure screws 5.41mm shorter than the actual overall screw length. thus when using the measuring gauge the surgeon would potentially be inserting a screw which is 5.41mm shorter than intended.

Device

GRAPHIC CASES FOR 6.5MM & 7.3MM CANNULATED SCREW SETS
  • Modèle / numéro de série
    Model Catalog: 690.379-US (Lot serial: H340372); Model Catalog: 690.375-US (Lot serial: H340372); Model Catalog: 690.380-US (Lot serial: FL00860); Model Catalog: 690.379-US (Lot serial: FL00860); Model Catalog: 690.380-US (Lot serial: H340372); Model Catalog: 690.375-US (Lot serial: FL00860)
  • Description du dispositif
    GRAPHIC CASES FOR 6.5MM & 7.3MM CANNULATED SCREW SETS
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.