China NMPA Product Recall - Bone Powered Surgical System

The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Stryker Instruments, reported by Stryker (Beijing) Medical Devices Co., Ltd. on October 8, 2024 (Index No. JGXX-2024-10166). This action concerns the Bone Powered Surgical System (Recall No. 20162042965). The main issue identified was endotoxin levels exceeding established limits within the product. The regulatory framework for this recall is provided by the NMPA in China. The required action is a voluntary recall by the manufacturer. It is specified that the products involved in this particular recall were not imported into China. The document did not provide specific inspection dates, but the voluntary recall demonstrates the company's responsiveness to quality issues under NMPA's oversight. Further details regarding specific models, specifications, and batches are available in the Medical Device Recall Event Report Form.