China NMPA Product Recall - Manual tools for total knee replacement surgery (3-4 cruciate ligament-preserving joint specimens)

The National Medical Products Administration (NMPA) issued a notice regarding a voluntary recall initiated by Smith & Nephew, Inc. Orthopaedics Division. The recall, reported on July 12, 2013, and publicly announced on July 30, 2013, concerns specific manual tools for total knee replacement surgery (CFDA Import Registration No.: 20101101935). The primary issue stemmed from a manufacturing error where incorrect coloring materials were used for one batch (Model: 71430490, Batch: 12LM03798) of "Cruciate Ligament Preservation Joint Specimen 3-4." This batch was inadvertently produced in red, a color intended for deep disc tibial liner implantation, instead of the correct blue for cruciate ligament preservation joint implantation. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., the local responsible unit, confirmed that the affected product batch was not imported into China and therefore had no impact on the Chinese market. The recall affected regions including Germany, the UK, France, and Dubai. Under the NMPA's regulatory framework, all provincial and municipal food and drug administration departments were instructed to enhance supervision and management of similar medical devices to ensure public safety.