Events

Rappel de SPEEDBRIDGE IMPLANT SYSTEM WITH BIOCOMPOSITE SWIVELOCK SP (SHOULDER)

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

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
    77072
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-04-06
  • 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
    The self-punching eyelet contained within the arthrex swivelock sp suture anchor has the potential to break on insertion in hard cortical bone. there is no impact to the patient if the device has been implanted successfully.

Device

SPEEDBRIDGE IMPLANT SYSTEM WITH BIOCOMPOSITE SWIVELOCK SP (SHOULDER)
  • Modèle / numéro de série
    Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10081420); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10081420); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10076852); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10076852); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10076753); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10076753); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10084027); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10084027); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10074288); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10074288); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10074291); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10074291); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10075965); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10075965); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10077252); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10077252); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10070003); Model Catalog: AR-26
  • Description du dispositif
    SPEEDBRIDGE IMPLANT SYSTEM With BIOCOMPOSITE SWIVELOCK SP (SHOULDER);PEEK SWIVELOCK SELF-PUNCHING;BIO-COMPOSITE SWIVELOCK SELF-PUNCHING;BIO-SWIVELOCK SELF-PUNCHING
  • Manufacturer
    ARTHREX INC

Manufacturer

ARTHREX INC
  • Adresse du fabricant
    NAPLES
  • Société-mère du fabricant (2017)
    Arthrex Inc.
  • Source
    HC