Events

Rappel de T-PAL SPACER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SYNTHES (CANADA) LTD..

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
    51652
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2011-09-13
  • 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
    Synthes (canada) ltd. is initiating a medical device labelling recall related to the synthes t-pal spacer system specifically regarding the use of the t-pal spacer with allograft material. this action has been initiated following a regulatory review of all labelling and promotional materials associated with the t-pal spacer system which is currently only indicated for use with autograft. there have been no additional risks to the patient identified associated with the use of the t-pal spacer system with allograft material.

Device

T-PAL SPACER
  • Modèle / numéro de série
    Model Catalog: 08.812.217 (Lot serial: ALL LOTS); Model Catalog: 08.812.007 (Lot serial: ALL LOTS); Model Catalog: 08.812.215 (Lot serial: ALL LOTS); Model Catalog: 08.812.214 (Lot serial: ALL LOTS); Model Catalog: 08.812.213 (Lot serial: ALL LOTS); Model Catalog: 08.812.212 (Lot serial: ALL LOTS); Model Catalog: 08.812.211 (Lot serial: ALL LOTS); Model Catalog: 08.812.210 (Lot serial: ALL LOTS); Model Catalog: 08.812.209 (Lot serial: ALL LOTS); Model Catalog: 08.812.208 (Lot serial: ALL LOTS); Model Catalog: 08.812.207 (Lot serial: ALL LOTS); Model Catalog: 08.812.017 (Lot serial: ALL LOTS); Model Catalog: 08.812.016 (Lot serial: ALL LOTS); Model Catalog: 08.812.015 (Lot serial: ALL LOTS); Model Catalog: 08.812.014 (Lot serial: ALL LOTS); Model Catalog: 08.812.013 (Lot serial: ALL LOTS); Model Catalog: 08.812.012 (Lot serial: ALL LOTS); Model Catalog: 08.812.011 (Lot serial: ALL LOTS); Model Catalog: 08.812.010 (Lot serial: ALL LOTS); Model Catalog: 08.812.009 (Lot serial: ALL LOTS); Model Catalog: 08.812.0
  • Description du dispositif
    T-PAL SPACER BROCHURE
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    HC