Events

Recall of DHS blades in steel and titanium

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 SYNTHES.

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
  • Date
    2008-04-21
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-de-lames-dhs-en-acier-et-en-titane-de-la-societe-synthes
  • 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
    On April 18, 2008, the company SYNTHES removed from the market all batches of references attached to the medical device called "blades DHS steel and titanium", following a complaint mentioning the separation of the proximal portion of the blade. The company SYNTHES has directly notified the recipients of the incriminated lots with the message attached (18/04/2008) (29 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

DHS blades in steel and titanium
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    SYNTHES

Manufacturer

SYNTHES