Events

Recall of PiGalileo Curved Impactor

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Smith & Nephew.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    201515819
  • Date
    2015-12-04
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/instrument-pour-pth-impacteur-courbe-pigalileo-smith-nephew-rappel-de-lots
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    The ANSM has been informed of the implementation of a security / batch withdrawal / product withdrawal action carried out by SMITH & NEPHEW ORTHOPEDICS AG. The users concerned received the attached mail (04/12/2015) (102 KB). This safety action is registered at ANSM under the number 201515819. You will be able to check its progress on the Directory of Materielovigilance Reports. by entering this registration number

Device

PiGalileo Curved Impactor
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew