AFSSAPS loses patience with implants firm:
This article was originally published in Clinica
Executive Summary
The French healthcare products safety agency, AFSSAPS, has issued a decision banning the further sale and use of a series of medical implantables manufactured by French company, Proconcept, for orthopaedic surgery. The CE marking certificates had expired on the products in February, a fact drawn to the attention of the agency by Proconcept's notified body, TUV Rheinland Product Safety (Germany). The French national society for certification and registration had also mentioned the expired certificate to the French authorities. Despite a series of warnings, the company has not responded to the French authorities. Therefore, the distribution, export and use of the LIFEC lumbar cage, the CIFEC cervical cage, the SRE/SEO lumbar screw systems and the Canaletto carpian canal protectors are banned for all products that were manufactured between February 16 and June 9 2005, bearing the label reference 0197 TUV Rheinland notified body number.