Events

Recall of ACE ATN

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 Depuy.

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
    2003-12-24
  • 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-tous-les-lots-de-la-gamme-des-clous-trochanteriens-ace-atn-societe-depuy
  • 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
    In agreement with AFSSAPS, the company Depuy proceeded on December 24, with the removal of all the batches of the range of trochanteric nails ACE ATN. On this day the 16 health institutions concerned by this withdrawal received the attached letter (24/12/2003) (20 KB). The withdrawal is global. This decision of withdrawal intervenes following 3 cases of migration of cervico-cephalic screws in the abdominal cavity. No cases have been reported in France. Depuy SA recommends that surgeons perform a clinical and radiological follow-up of implanted patients, especially at three months and until the fracture is consolidated.

Device

ACE ATN
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Depuy

Manufacturer

Depuy