Events

Recall of Cemented PF femoral stems, 11.7 mm thin neck

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 Centerpulse.

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
    2004-08-23
  • 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-tiges-femorales-de-protheses-de-hanche-de-la-societe-centerpulse
  • 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
    Centerpulse informed AFSSAPS on August 18, 2004, that it was recalling all batches of cemented PF femoral stems, 11.7 mm thin neck, with a half-moon of impaction centered. Although no breakage of these femoral stems was reported in materiovigilance, Centerpulse took this action following the various recalls made on similar devices of different brand design. Users of this device have received the attached mail (23/08/2004) (16 KB). The other competent European authorities have not been informed of this measure, France being the only country concerned by this recall. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to orthopedic surgeons.

Device

Cemented PF femoral stems, 11.7 mm thin neck
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Centerpulse

Manufacturer

Centerpulse
  • Source
    LAANSM