Events

Rappel de S4 OCCIPITAL CERVICAL SPINAL SYSTEM - OCCIPITAL PLATE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par AESCULAP IMPLANT SYSTEMS LLC.

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
    19048
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-07-31
  • 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
    Ifu does not contain instructions how to reassemble the torque wrench after reprocessing.

Device

S4 OCCIPITAL CERVICAL SPINAL SYSTEM - OCCIPITAL PLATE
  • Modèle / numéro de série
    Model Catalog: SW205T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW202T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW203T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW204T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW002T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW003T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW216T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW126T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW214T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW213T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW212T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW211T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW210T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW209T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW208T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW207T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW206T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW134T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW133T (Lot serial: ALL LOT NUMBERS); Model Catalog: S
  • Description du dispositif
    S4 OCCIPITAL PLATE
  • Manufacturer
    AESCULAP IMPLANT SYSTEMS LLC

Manufacturer

AESCULAP IMPLANT SYSTEMS LLC