China NMPA Product Recall - Interbody fusion device

NuVasive Inc. (USA) has initiated a voluntary Class III recall of its interbody fusion devices (National Medical Device Registration Certificate 20153460649) in China. This action, reported by Beijing Yingpulangte Trade Co., Ltd., follows the discovery of non-compliance with product dimensional requirements during national medical device sampling inspections. The incident report was dated January 17, 2019, and published by the National Medical Products Administration (NMPA) on January 24, 2019. The affected devices, including model 6808714 and identified by PT3308, are designed as stand-alone anterior cervical interbody fusion systems for skeletally mature patients with C2-T1 intervertebral disc degenerative diseases, used in conjunction with autologous grafts. While twenty production batches were impacted, no units of the affected products were sold within China, mitigating direct patient risk. The recall requires NuVasive Inc. to undertake corrective actions, including internal self-inspection and the strengthening of internal acceptance procedures to prevent future occurrences of such dimensional non-compliance. This regulatory action underscores the NMPA's commitment to ensuring the safety and quality of medical devices circulated within China.