Events

Rappel de SUMMIT OCT SPINAL SYSTEM - TRANS CONNECTOR HOOK

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
    90370
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-09-28
  • 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 synthes cranial flap tube clamp and crimping device for cranial tube clamp had been labelled mr safe and now must be labelled mr conditional. the company does not have the testing protocols currently required to designate them as mr safe.

Device

SUMMIT OCT SPINAL SYSTEM - TRANS CONNECTOR HOOK
  • Modèle / numéro de série
    Model Catalog: 460.107.01S (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.107 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.008.01S (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.008 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.009.01S (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.010 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.010.01S (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.001.01S (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.002 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.002.01S (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.003 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.003.01S (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.100 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.100.01S (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.009 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 460.001 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    SUMMIT OCT SPINAL SYSTEM - TRANS CONNECTOR HOOK
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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