China NMPA Product Recall - microelectrodes

Medtronic (Shanghai) Management Co., Ltd., on behalf of manufacturer FHC, Inc., initiated a voluntary Class III recall of specific microelectrodes. The recall was reported to China's National Medical Products Administration (NMPA) on June 28, 2017, and the NMPA publicized the notice on September 13, 2017. The core issue for this action was incorrect labeling on the inner packaging of microelectrode model 22670, batch number 212492. The inner label erroneously listed the product model as 'FC8011,' despite the outer box correctly identifying the product. These microelectrodes are used in surgical settings for recording single neuron activity and electrical stimulation. While the recall impacted international regions such as France, Norway, Poland, Switzerland, USA, and the Netherlands, no affected units were imported or sold within China. Therefore, under the NMPA's regulatory framework, no specific corrective actions or follow-up measures are required from Medtronic (Shanghai) or other Chinese entities. The recall addresses a labeling discrepancy with no direct impact on the Chinese market.