China NMPA Product Recall - Total Hip System

The National Medical Products Administration (NMPA) announced a voluntary recall by MicroPort Orthopedics, Inc. for its Total Hip System, specifically the "BIOLOX FORTE 36mm Ceramic Femoral Head," as detailed in a recall report by Shanghai MicroPort Orthopedic Medical Technology Co., Ltd. on March 6, 2017, and published by the NMPA on March 17, 2017. The primary issue identified was that the BIOLOX FORTE 36mm Ceramic Femoral Head is approximately 2mm shorter than other compatible femoral heads, such as MicroPort's 36mm Cobalt Chrome and Biolux DELTA Ceramic heads. This size discrepancy poses a risk of joint laxity and/or dislocation, which could necessitate revision surgery for patients. Operating under the NMPA's regulatory framework, MicroPort Orthopedics, Inc. initiated the global recall. Importantly, investigations confirmed that the recalled product had not been sold or imported into the Chinese market. As a required action, the NMPA directed relevant local Food and Drug Administrations to enhance their supervision and management of similar medical devices to ensure continued product safety and public health protection.