China NMPA Product Recall - Knee prosthesis (trade name: NexGen)

On December 7, 2015, Zimmer Inc. initiated a global voluntary recall of its NexGen Knee Prosthesis, specifically batch number 62460264. This action was prompted by two main issues: general product confusion and the absence of a seal on the Tyvek cap edge of the inner packaging for the specified batch. The recall was reported to the National Medical Products Administration (NMPA), then known as the China Food and Drug Administration (CFDA), by Zimmer (Shanghai) Medical International Trading Co., Ltd., the product's Chinese distributor. Although the NexGen Knee Prosthesis is registered under CFDA (Imported) 2012 No. 3462713, the affected batch was explicitly confirmed not to have been sold or imported into China. As a result, no units of the problematic batch were distributed within the country, and no related complaints were received from the Chinese market. Under the NMPA's regulatory framework, provincial and municipal Food and Drug Administrations were instructed to strengthen their oversight of similar medical devices. No specific corrective actions were necessary within China due to the absence of the affected products in its market.