Events

Recall of Osteosynthesis plates

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
    2004-10-18
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-plaques-d-osteosynthese-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
    Afssaps was informed on 27 September 2004 by the company Mathys Medical France of a withdrawal from the market on September 24, 2004, references and batches listed in the appendix, the medical device called osteosynthesis plates (manufactured by SYNTHES) more risk of contamination by residues of oil, water and dust .. The company Mathys Medical France directly notified the recipients of the incriminated lots with the message attached (18/10/2004) ( This information is addressed to local directors and correspondents of materiovigilance for dissemination to the departments concerned. The relevant European Competent Authorities have been informed of this measure by the manufacturer. Synthes Mail (18/10/2004) (46 KB)

Device

Osteosynthesis plates
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    SYNTHES

Manufacturer

SYNTHES