China NMPA Product Recall - Rotating hinge type knee joint system (trade name: S-Rom Noiles)

On April 4, 2014, the National Medical Products Administration (NMPA) announced a voluntary recall initiated by DePuy Orthopaedics, Inc. (USA) for its Rotary Hinge Knee Joint Systems (S-Rom Noiles). The recall was reported to the NMPA by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the distributor in China. The primary issue involved 45 reports, received between 1999 and 2013, detailing holes found in the sterile bags of the product. This packaging defect, with a complaint rate of 0.35% from 2010-2013, was attributed to damage sustained during repeated shipments over several years, potentially compromising product sterility.

Operating under the NMPA's regulatory oversight, the recall was global, affecting numerous countries. However, Johnson & Johnson (Shanghai) explicitly confirmed that the specific batch numbers identified as problematic were not imported into China. Therefore, while the situation was reported to the NMPA, no further direct actions, such as investigations or implementation plans, were deemed necessary or taken for the Chinese market. The NMPA subsequently instructed provincial and local food and drug administrations to strengthen general supervision and management concerning medical devices.