China NMPA Product Recall - Total Hip System

The National Medical Products Administration (NMPA) issued a notice on March 16, 2017, detailing a global voluntary recall initiated by MicroPort Orthopedics, Inc. The recall pertains to their Total Hip System, specifically the "BIOLOX FORTE 36mm Ceramic Femoral Head" component. Investigations confirmed this ceramic femoral head is approximately 2mm shorter than standard 36mm cobalt-chromium-molybdenum and Biolox DELTA ceramic femoral heads. This dimensional discrepancy poses a significant risk, potentially causing joint laxity and/or dislocation, which could necessitate revision surgery for patients. The recall falls under the NMPA's regulatory oversight, referencing medical device registration number 20153461657. While MicroPort Orthopedics, Inc. is the manufacturer, its Chinese distributor, Shanghai MicroPort Orthopedic Medical Technology Co., Ltd., confirmed that the recalled product was not sold in China. Nonetheless, the NMPA directed all provincial Food and Drug Administrations to enhance supervision and management of similar products. The required action was a global voluntary recall covering all affected batch numbers and models (26000010, 26000011, 26000012).