Events

Rappel de CONFIDENCE INTRODUCER NEEDLE SIDE HOLE

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
    154027
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-05-25
  • 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
    During post market surveillance review of the confidence spinal cement system it was found that the complaint rate for breakage of the side fire needles was higher than the anticipated occurrence rate. to reduce the level of risk a communication has been sent out to all users of the product to reinforce proper technique and instructions for use.

Device

CONFIDENCE INTRODUCER NEEDLE SIDE HOLE
  • Modèle / numéro de série
    Model Catalog: 2839-04-613 (Lot serial: HLDB5L); Model Catalog: 2839-04-411 (Lot serial: HLFBC4); Model Catalog: 2839-04-611 (Lot serial: HLFBC4); Model Catalog: 2839-04-613 (Lot serial: HLFBC4); Model Catalog: 2839-04-411 (Lot serial: HLDB02); Model Catalog: 2839-04-411 (Lot serial: HLDB5L); Model Catalog: 2839-04-613 (Lot serial: HLDB02); Model Catalog: 2839-04-611 (Lot serial: HLDB02); Model Catalog: 2839-04-611 (Lot serial: HLDB5L); Model Catalog: 2839-04-413 (Lot serial: HLKBDD); Model Catalog: 2839-04-413 (Lot serial: CJNBWN); Model Catalog: 2839-04-413 (Lot serial: CJPCBZ); Model Catalog: 2839-04-413 (Lot serial: CJPB8Z); Model Catalog: 2839-04-413 (Lot serial: CJPCB1); Model Catalog: 2839-04-413 (Lot serial: CKBBW5)
  • Description du dispositif
    CONFIDENCE SPINAL SIDE FIRE NEEDLES
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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