China NMPA Product Recall - PROFEMUR Z Classic Stems

MicroPort Orthopedics, Inc. initiated a voluntary Class II recall of its PROFEMUR Z Classic Femoral Stems, as announced by the National Medical Products Administration (NMPA) on July 18, 2022. The recall was prompted by a manufacturing defect identified in specific models and batches of the product. The core issue involves the absence of plasma spray coating in certain proximal areas of the affected femoral stems. This significant quality deviation could potentially impact the product's intended function and patient safety. Shanghai MicroPort Orthopedic Medical Technology Co., Ltd. reported this issue to the NMPA, leading to the manufacturer's decision to recall the products. While no specific inspection dates are mentioned, the recall notification serves as the regulatory action taken. The NMPA oversees such medical device recalls within its jurisdiction, ensuring product safety and quality. The required action for MicroPort Orthopedics, Inc. is to execute this voluntary recall, addressing the identified product deficiencies to prevent potential harm to patients. Detailed information regarding the affected product models, specifications, and batch numbers is available in the "Medical Device Recall Event Report Form" attachment.