Events

Rappel de DELTA XTEND REVERSE SHOULDER SYSTEM - MODULAR ECCENTRIC EPIPHYSIS

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
    72979
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-09-15
  • 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 initiating a voluntary recall. for the recalled lots an investigation determined that lots produced in a specific machine were manufactured in a manner in which the post's diameter is out-of-specification. further investigation determined that the issue is related to the circularity of the cylinder. the circularity issue may cause the epiphysis to interfere with the stem and the two implants (epiphysis and stem) may not be able to be assembled.

Device

DELTA XTEND REVERSE SHOULDER SYSTEM - MODULAR ECCENTRIC EPIPHYSIS
  • Modèle / numéro de série
    Model Catalog: 130720203 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720201 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720101 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720102 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720202 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720103 (Lot serial: >100 NUMBERS CONTACT MFG)
  • Description du dispositif
    DELTA XTEND REVERSE SHOULDER SYSTEM - MODULAR ECCENTRIC EPIPHYSIS;DELTA XTEND REVERSE SHOULDER SYSTEM -MODULAR CEMENTED EPIPHYSIS
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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