Events

Rappel de RIA SYSTEM - REAMER HEAD STERILE

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
    55733
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-06-15
  • 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
    Synthes canada ltd. is initiating a voluntary medical device labelling recall for synthes reamer/irrigator /aspirator (ria) system technique guide (j4352). precautionary statements are being added to the "reamer /irrigator/ aspirator (ria) surgical technique guide". it was reported that the ria drive shaft tube assembly and reamer head have the potential to break when incorrectly assembled or used improperly as follows: 1. failure to fully engage the reamer to shaft at assembly prior to surgery. incorrect assembly creates a reduced reamer/shaft contact surface area in which excess rotational forces could cause breakage 2. use of ria drive shafts after the flats have become worn and rounded 3. use of any excess force beyond design limit 4. use of with an incompatible power tool.

Device

RIA SYSTEM - REAMER HEAD STERILE
  • Modèle / numéro de série
    Model Catalog: 352.263S (Lot serial: All revisions); Model Catalog: 352.262S (Lot serial: All revisions); Model Catalog: 352.261S (Lot serial: All revisions); Model Catalog: 352.259S (Lot serial: All revisions); Model Catalog: 352.250S (Lot serial: All revisions); Model Catalog: 352.257S (Lot serial: All revisions); Model Catalog: 352.256S (Lot serial: All revisions); Model Catalog: 352.255S (Lot serial: All revisions); Model Catalog: 352.254S (Lot serial: All revisions); Model Catalog: 352.253S (Lot serial: All revisions); Model Catalog: 352.252S (Lot serial: All revisions); Model Catalog: 352.251S (Lot serial: All revisions); Model Catalog: 352.264S (Lot serial: All revisions); Model Catalog: 352.265S (Lot serial: All revisions); Model Catalog: 352.258S (Lot serial: All revisions); Model Catalog: 314.743 (Lot serial: All revisions); Model Catalog: 314.742 (Lot serial: All revisions); Model Catalog: 314.745S (Lot serial: All revisions); Model Catalog: 314.746S (Lot serial: All revisions)
  • Description du dispositif
    RIA SYSTEM - REAMER HEAD STERILE
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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