Events

Rappel de COCR DYNAMIC LOCKING SCREW SELF TAPPING

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
    45089
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-06-25
  • 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 recall of all lots of the 3.7mm and 5.0mm dynamic locking screw (dls). the voluntary recall is being initiated following synthes' receipt of customer complaints of 3.7 and 5.0 mm dls breakages at the distal tip of the pin identified after successful healing and during planned implant removal of the whole construct. there have been no reports of permanent impairment associated with the reason for this recall to date. however synthes is aware that significant elongation of surgical time has occurred in planned implant removals which involved a broken dls screw.

Device

COCR DYNAMIC LOCKING SCREW SELF TAPPING
  • Modèle / numéro de série
    Model Catalog: 09.213.022S (Lot serial: all lots); Model Catalog: 09.223.090S (Lot serial: all lots); Model Catalog: 09.223.085S (Lot serial: all lots); Model Catalog: 09.223.080S (Lot serial: all lots); Model Catalog: 09.223.075S (Lot serial: all lots); Model Catalog: 09.223.070S (Lot serial: all lots); Model Catalog: 09.223.065S (Lot serial: all lots); Model Catalog: 09.223.060S (Lot serial: all lots); Model Catalog: 09.223.058S (Lot serial: all lots); Model Catalog: 09.223.056S (Lot serial: all lots); Model Catalog: 09.223.055S (Lot serial: all lots); Model Catalog: 09.223.054S (Lot serial: all lots); Model Catalog: 09.223.052S (Lot serial: all lots); Model Catalog: 09.223.050S (Lot serial: all lots); Model Catalog: 09.223.048S (Lot serial: all lots); Model Catalog: 09.223.046S (Lot serial: all lots); Model Catalog: 09.223.044S (Lot serial: all lots); Model Catalog: 09.223.042S (Lot serial: all lots); Model Catalog: 09.223.040S (Lot serial: all lots); Model Catalog: 09.223.038S (Lot serial: all lots); Mod
  • Description du dispositif
    COCR DYNAMIC LOCKING SCREW SELF TAPPING
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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