Events

Rappel de EMAX SAGITTAL SAW - MOTOR

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
    55119
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-05-30
  • 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) was advised that anspach identified through internal sterility assurance level (sal)validation testing that several attachments failed to meet 10-6 sal when sterilized by the sterrad 100s sterilization method that is specified in the current directions for use (dfu) and operating manuals provided with the device.

Device

EMAX SAGITTAL SAW - MOTOR
  • Modèle / numéro de série
    Model Catalog: MM-SAGITTAL (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: DRIVER (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: S-SAW (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: SHORT (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: MEDIUM (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: LONG (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: O-SAW (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: B-SILVER (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: ADG (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: BLACKMAX-N (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: BLACKMAX-O (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: CRANI-A-R (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: EMAX2-HC (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: CRANI-A (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: CRANI-L (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: CRAN
  • Description du dispositif
    EMAX SAGITTAL SAW - MOTOR
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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