China NMPA Product Recall - Hip joint femoral component

The National Medical Products Administration (NMPA) notice JGXX-2021-10154, published on March 31, 2021, details a voluntary Class II recall initiated by Shanghai MicroPort Orthopedics Medical Technology Co., Ltd. This action concerns specific hip joint femoral components, manufactured by MicroPort Orthopedics Inc. (Registration Certificate No.: 20173466148).

The recall was prompted by fracture complaints involving the Profemur split long femoral neck. Despite a significantly lower incidence rate in China (0.015%) and Japan (0.009%) compared to the global average (0.55%), the company proceeded with the recall to prevent potential patient harm. An analysis identified product-related factors contributing to the risk, including patient selection, surgical technique, and design elements.

In adherence to regulatory requirements set forth by the NMPA, Shanghai MicroPort Orthopedics Medical Technology Co., Ltd. is undertaking this voluntary recall. While no specific inspection dates were cited, this action underscores the company's commitment to medical device safety standards. Comprehensive details regarding the affected product models, specifications, and batch numbers are provided in an attached Medical Device Recall Event Report Form.