Events

Rappel de 6.5MM CANNULATED SCREW

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
    60309
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-03-11
  • 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
    It was reported that affected labelling (technique guides j2455 and j3270) may contain information regarding the use of some cannulated cortex and cancellous screws that do not match the cleared indications for use in canada. all affected labelling will be corrected to include only the correct indications.

Device

6.5MM CANNULATED SCREW
  • Modèle / numéro de série
    Model Catalog: 208.404 (Lot serial: N/A); Model Catalog: 208.403 (Lot serial: N/A); Model Catalog: 208.402 (Lot serial: N/A); Model Catalog: 208.401 (Lot serial: N/A); Model Catalog: ALL PART NUMBERS (Lot serial: N/A); Model Catalog: 208.480-208.487 (Lot serial: N/A); Model Catalog: 208.47-208.479 (Lot serial: N/A); Model Catalog: 208.46-208.469 (Lot serial: N/A); Model Catalog: 208.455 (Lot serial: N/A); Model Catalog: 208.454 (Lot serial: N/A); Model Catalog: 208.453 (Lot serial: N/A); Model Catalog: 208.452 (Lot serial: N/A); Model Catalog: 208.451 (Lot serial: N/A); Model Catalog: 208.450 (Lot serial: N/A); Model Catalog: 208.448 (Lot serial: N/A); Model Catalog: 208.447 (Lot serial: N/A); Model Catalog: 208.446 (Lot serial: N/A); Model Catalog: 208.445 (Lot serial: N/A); Model Catalog: 208.444 (Lot serial: N/A); Model Catalog: 208.443 (Lot serial: N/A); Model Catalog: 208.442 (Lot serial: N/A); Model Catalog: 208.449 (Lot serial: N/A); Model Catalog: 208.441 (Lot serial: N/A); Model Catalog: 208.440 (Lo
  • Description du dispositif
    6.5MM CANNULATED SCREW;CANNULATED SCREW;7.0MM CANNCELLOUS SCREW;4MM TI CANNULATED SCREW SHORT THREAD;4.5MM CANN SCREW PAR. THRD.;3.5/4.0 MM CANNULATED SCREW IMPLANT SET AND INSTRUMENTS;7.3MM CANNULATED SCREW;CORTEX SCREWS (PURE TITANIUM);6.5MM TITANIUM CA
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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