Events

Recall of XVOID expander manufactured

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 Sintea Biotech Spa.

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-expanseurs-xvoid-stryker
  • 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 28/03/08, the company Stryker withdrew lots 02498 from the market; 02518; 02532 and 02572 references SPS10N120 and SPS10N125 of the medical device called XVOID expander manufactured by Sintea Biotech Spa, following a disassembly of the end of the expansors .. The company Stryker directly notified the recipients of the incriminated lots with the help of attached message (02/04/2008) (30 ko) validated by Afssaps. This information is addressed to directors and correspondents of materiovigilance for dissemination, where appropriate, to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

XVOID expander manufactured

Manufacturer

Sintea Biotech Spa
  • Source
    LAANSM