UK REGULATORY AGENCY ISSUES ALERT FOR ORTHOPEDIC DEVICES

The MHRA said the French Medical Device Regulator informed the agency that:

• Orthopedic implants manufactured by Proconcept SA have invalid CE certification, a lack of technical documentation as well as production and traceability deficiencies;
  
• Proconcept SA in France has now ceased trading and gone bankrupt; and
  
• Some of the affected products (LIFEC lumbar cages) have been distributed in the UK by Kuma Trading of Basildon Essex, which the MHRA has been unable to trace.

The MHRA noted it had received no reports of adverse incidents involving implantable devices manufactured by Proconcept SA. "There is currently no evidence to suggest that clinical problems are more likely in patients implanted with these devices," the agency said.

The MHRA alert can be viewed at www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=
CON2024591&ssTargetNodeId=834.