China NMPA Product Recall - Total Hip System

The National Medical Products Administration (NMPA) issued an alert on March 16, 2017, concerning a voluntary recall initiated by MicroPort Orthopedics, Inc., regarding its Total Hip System. The recall, detailed in a report dated February 24, 2017, from the Chinese responsible unit, Shanghai MicroPort Orthopedic Medical Technology Co., Ltd., addresses a critical manufacturing deviation. The primary issue involves the "BIOLOX FORTE 36mm Ceramic Femoral Head" component of the Total Hip System (NMPA Registration Certificate No. 20153461657). Investigations confirmed this specific ceramic femoral head is approximately 2mm shorter than the corresponding MicroPort 36mm Cobalt Chrome and Biolox DELTA Ceramic femoral heads. This dimensional inconsistency poses a significant patient risk, as it may lead to joint laxity and/or dislocation, potentially necessitating additional revision surgery for patients. MicroPort Orthopedics, Inc. voluntarily recalled the affected product globally. Importantly, checks of import records confirmed that the recalled product batches were not sold or imported into the Chinese market. In response, the NMPA directed all provincial and municipal Food and Drug Administrations within China to intensify oversight and management of similar medical devices to safeguard public health.