Events

Recall of SAMARYS cervical cage

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 SCIENT X.

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
    2008-03-11
  • 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-lot-de-cage-cervicale-samarys-de-la-societe-scient-x
  • 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 7, 2008, SCIENT'X withdrew from the market the batch 955P of the 11CC2AC17-5S reference of the medical device called "anatomical anterior cage cervical short width 17 size 5 sterile family SAMARYS", manufactured by SCIENT'X, following a discrepancy between the references indicated on the external labeling of the box and the internal labeling (secondary bag and self-adhesive labels). SCIENT'X directly informed the recipients of the incriminated lot with the help of the message below. attached (07/03/2008) (14 ko) validated by Afssaps .. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. This recall only concerns France.

Device

SAMARYS cervical cage
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    SCIENT X

Manufacturer

SCIENT X
  • Manufacturer Parent Company (2017)
    Scientx SA
  • Source
    LAANSM