China NMPA Product Recall - Inverted shoulder joint system

The National Medical Products Administration (NMPA) issued a notice on February 21, 2017, detailing a voluntary global recall initiated by Biomet Orthopedics. This recall, reported by its Chinese distributor Zimmer Medical (Shanghai) International Trading Co., Ltd., concerned the Inverted Shoulder Joint System. The primary issue identified was a potentially higher-than-expected crushing rate in the titanium alloy humeral bone component of products manufactured before September 2011. Biomet Orthopedics took the proactive step to recall these specific batches. Importantly, the affected products were not sold in China, and no related complaints were reported within the country. To mitigate future risks, all products manufactured after September 2011 were redesigned to enhance their strength. Operating under its medical device regulatory framework, the NMPA directed all provincial Food and Drug Administrations to strengthen their oversight and management concerning such medical devices, ensuring continued patient safety and product quality.