Europe’s medicines regulator recommended the suspension of Medtronic Plc’s Inductos, an implant used to help bone development, pending the resolution of issues at a U.S. site where a component is made.
The European Medicines Agency (EMA) began a review of Inductos following an inspection by Dutch and Spanish authorities of a site that makes an absorbable sponge used in the implant.
It said on Friday that the manufacturer did not comply with its requirements because it lacks adequate measures to prevent particle contamination of the sponges.
