Events

Recall of Helianthe Hip Resin Rods

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 Wright Medical Technology - EMEA.

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
    2008-04-02
  • 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-tiges-de-protheses-de-hanche-helianthe-societe-wright-medical-technology-emea
  • 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 March 31, 2008, Wright Medical Technology - EMEA withdrew from the market the batches of the references contained in the attached medical device message called Helianthe Hip Resin Rods, manufactured by Wright Medical Technology, Inc., continued a non-conformity of the rods to the manufacturing specifications regarding the anteroposterior width (A / P) of the proximal end of the rod. Indeed, these devices are slightly undersized at the thickest point of the proximal width. The company Wright Medical Technology - EMEA has directly notified the recipients of the offending lots with the enclosed message validated ( 02/04/2008) (78 ko) by Afssaps. This information is intended for surgeons for dissemination to the relevant services where applicable. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Helianthe Hip Resin Rods

Manufacturer

Wright Medical Technology - EMEA