Events

Recall of zirconia heads 28/0 - Depuy Companies, Hospital Supplies, Smith + Nephew

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
    2001-07-23
  • 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-tetes-zircone-28-0-societes-depuy-fournitures-hospitalieres-smith-nephew
  • 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
    About thirty cases of rupture of ceramic heads of hip prostheses marketed by the company Depuy have been reported as part of materiovigilance. It has been shown that the femoral heads concerned by these ruptures are from a single batch Manufacturer Saint-Gobain Advanced Ceramics Demarquets, comprising 684 pieces. Three other manufacturers also received parts of this lot: Smith + Nephew France, Hospital Supplies Industry, Smith + Nephew USA .. The recall of all non-implanted parts was done by the four manufacturers concerned. Information for health facility and orthopedic directors who received these implants was distributed by manufacturers Depuy and Smith + Nephew so that patients would be aware of the high risk of early rupture of these implants.

Device

zirconia heads 28/0 - Depuy Companies, Hospital Supplies, Smith + Nephew
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Depuy

Manufacturer

Depuy