Events

Recall of LIFEC lumbar cages;CIFEC cervical cages;SRE / SEO lumbar screw systems;carpal tunnel protectors CANALETTO

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 PROCONCEPT.

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
    2006-03-06
  • 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-dispositifs-medicaux-fabriques-par-proconcept
  • 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
    In the context of the decision of 27 June 2005 (27/06/2005) (41 ko) on animal health, suspending the placing on the market, the distribution, the export and the use of implantable medical devices called LIFEC lumbar cages, CIFEC cervical cages, SRE / SEO lumbar screw systems and carpal tunnel protectors CANALETTO, manufactured between February 16, 2004 and June 9, 2005 Afssaps ordered PROCONCEPT to recall the aforementioned medical devices. In view of the fact that the recall of batches has not been exhaustively and effectively carried out by the manufacturer and that, consequently, medical devices concerned by this decision (which do not have an EC certificate attesting to their compliance with the essential requirements ) are likely to remain in stock among users, Afssaps disseminates the list of devices and lots concerned (06/03/2006) (18 KB) to all health facilities (see tables attached). Thank you kindly isolate all units and return the attached form completed (06/03/2006) (21 KB), to the following fax number: 01 55 87 39 22. No report of materiovigilance has been reported to date on these devices. The competent European authorities concerned are informed by Afssaps. Animal health decision of 27 June 2005 (27/06/2005) (41 KB List of consignments concerned (06/03/2006) (18 KB Form (06/03/2006) (21 KB)

Device

LIFEC lumbar cages;CIFEC cervical cages;SRE / SEO lumbar screw systems;carpal tunnel protectors C...
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    PROCONCEPT

Manufacturer

PROCONCEPT
  • Source
    LAANSM