China NMPA Product Recall - Hip joint prosthesis (cobalt-chromium-molybdenum)

Tianxinfu (Beijing) Medical Devices Co., Ltd. initiated a voluntary Class III recall of its Hip Joint Prostheses (Cobalt Chromium Molybdenum) on July 22, 2019. This action followed a national medical device sampling inspection that identified a critical manufacturing defect. The primary violation involved the femoral head cone connection cone angle, which was found to exceed the allowable tolerance range specified in the company's own technical requirements. Under the regulatory oversight of the National Medical Products Administration (NMPA) of China, Tianxinfu (Beijing) Medical Devices Co., Ltd. reported this issue and outlined immediate corrective measures. These actions included sealing all remaining products within the affected batch (production batch number 1700929). Furthermore, the company committed to thoroughly analyzing the root causes of the non-compliance and implementing necessary rectifications. Out of the 40 affected units, 10 were used for the sampling inspection, and the remaining 30 units were handed over to the Beijing Food and Drug Administration for secure sealing, preventing any further distribution. This proactive recall aims to ensure patient safety by addressing the identified quality control lapse.