Events

Rappel de LCS COMPLETE KNEE SYSTEM - RPS FLEXION FEMORAL CEMENTED

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
    59041
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-03-09
  • 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 orthopaedics inc. is issuing a device correction for all lots of the lcs complete rps knee system and advising surgeons that the product labeling will be revised to include a warning that states the patella must be resurfaced when using this system. according to data from the australian orthopaedic association national joint replacement registry failure to resurface the patella has been associated with a higher incidence of postoperative patello-femoral pain potentially leading to a secondary procedure.

Device

LCS COMPLETE KNEE SYSTEM - RPS FLEXION FEMORAL CEMENTED
  • Modèle / numéro de série
    Model Catalog: 129412070 (Lot serial: ALL LOTS); Model Catalog: 129412060 (Lot serial: ALL LOTS); Model Catalog: 129412050 (Lot serial: ALL LOTS); Model Catalog: 129412040 (Lot serial: ALL LOTS); Model Catalog: 129412030 (Lot serial: ALL LOTS); Model Catalog: 129412020 (Lot serial: ALL LOTS); Model Catalog: 129412010 (Lot serial: ALL LOTS); Model Catalog: 129411070 (Lot serial: ALL LOTS); Model Catalog: 129411060 (Lot serial: ALL LOTS); Model Catalog: 129411050 (Lot serial: ALL LOTS); Model Catalog: 129411040 (Lot serial: ALL LOTS); Model Catalog: 129411030 (Lot serial: ALL LOTS); Model Catalog: 1294-16-622 (Lot serial: ALL LOTS); Model Catalog: 1294-16-620 (Lot serial: ALL LOTS); Model Catalog: 1294-16-617 (Lot serial: ALL LOTS); Model Catalog: 1294-16-615 (Lot serial: ALL LOTS); Model Catalog: 1294-16-612 (Lot serial: ALL LOTS); Model Catalog: 1294-16-610 (Lot serial: ALL LOTS); Model Catalog: 1294-16-525 (Lot serial: ALL LOTS); Model Catalog: 1294-16-522 (Lot serial: ALL LOTS); Model Catalog: 1294-16-520
  • Description du dispositif
    LCS COMPLETE KNEE - RPS FLEXION FEMORAL
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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