China NMPA Product Recall - Total Knee System (Brand Name: Genesis II) (Tibial Support Size 5 (Left) and Size 6 (Right))

Smith & Nephew, Inc. Orthopaedics Division initiated a voluntary recall of specific batches of its Total Knee System (Genesis II Tibial Support). This action, reported to the National Medical Products Administration (NMPA) on October 10, 2013, concerned product models 71420188 (Tibial Support No. 6, Right) and 71420168 (Tibial Support No. 5, Left). The primary issue stemmed from an internal process error, resulting in discrepancies between the labels affixed to the outer and inner packaging and the actual medical device. Specifically, some Genesis II non-pearl coated tibia support products were incorrectly labeled, with right-sided supports identified as left, and vice versa. This mislabeling could lead to incorrect product identification. Under the NMPA's regulatory oversight, Smith & Nephew confirmed that the affected product batches were not imported into or sold within China, therefore having no impact on the Chinese market. As a required action, the NMPA directed all provincial food and drug administrations to enhance their supervision and management of this product. The recall primarily affected regions outside of China, such as the USA.