China NMPA Product Recall - Total knee system

The National Medical Products Administration (NMPA) has announced a voluntary Class III recall initiated by Smith & Nephew, Inc., concerning a specific batch of its total knee system. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. reported this action, citing packaging issues identified with certain products within a single batch, numbered 20153133638. This recall, categorized as Class III, indicates that the affected products are unlikely to cause adverse health consequences. The primary issue driving this recall is packaging discrepancies that could potentially compromise product sterility or integrity. The required action involves the voluntary retrieval of the specified batch of products from the market. It is important to note that this particular recall does not affect the Chinese market. The company is undertaking this voluntary measure in adherence to global regulatory frameworks governing medical device safety and quality. Detailed information regarding affected product models, specifications, and batch numbers is available in the 'Medical Device Unrestricted List' and the 'Medical Device Recall Event Report Form' filed by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.