China NMPA Product Recall - Femoral condyle STATURE, Total Knee Repair System, Cementless

MicroPort Orthopedics, Inc. has initiated a voluntary Level III recall for specific batches of its femoral condyle (STATURE Femoral Component) and total knee repair system (ADVANCE Knee System Cementless). This action, reported by Shanghai MicroPort Orthopedic Medical Technology Co., Ltd. on May 29, 2025, addresses significant discrepancies identified between product label information and the actual products. Both devices are registered under National Medical Device Registration Certificates, signifying their regulatory status within the Chinese market, overseen by the National Medical Products Administration (NMPA).

The recall is classified as Level III, indicating that while issues were identified, the use of or exposure to the recalled products is not expected to cause serious adverse health consequences. A crucial detail is that the affected products were not imported into China, thereby mitigating direct risk to patients within the region. Comprehensive details regarding the specific models, specifications, and batch numbers involved are provided in an accompanying "Medical Device Recall Event Report Form." This voluntary measure underscores the manufacturer's commitment to product safety and adherence to NMPA regulatory standards.