China NMPA Product Recall - Metal femoral neck fixation nail

Shanghai Puwei Medical Device Factory Co., Ltd. proactively initiated a voluntary Class III recall for specific batches of its metal femoral neck fixation screws. This action, reported by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on August 23, 2019, addresses a critical product quality issue. An internal investigation conducted by the company identified incorrect labeling on eight batches of these medical devices (Registration Certificate No.: 20163462039). The primary concern is that this labeling inaccuracy could lead to product misuse in actual clinical settings, potentially affecting patient safety and treatment outcomes. To prevent any such misuse and uphold product integrity, Shanghai Puwei Medical Device Factory Co., Ltd. implemented the recall. This voluntary measure aligns with the regulatory framework overseen by the NMPA, demonstrating the company's commitment to correcting deficiencies and ensuring the safe and effective application of its medical products. The recall mandates the removal of all affected metal femoral neck fixation screws from circulation, with detailed information on the specific models, specifications, and batch numbers provided in the accompanying Medical Device Recall Event Report Form.