LIFEC lumbar cages;CIFEC cervical cages;SRE / SEO lumbar screw systems;carpal tunnel protectors CANALETTO 의 리콜

Recall

2006-03-06

France

ANSM

https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-dispositifs-medicaux-fabriques-par-proconcept

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)