China NMPA Product Recall - Inverted shoulder joint system

The National Medical Products Administration (NMPA) disseminated information on February 24, 2017, concerning a voluntary global recall initiated by Biomet Orthopedics for its Inverted Shoulder Joint System (Registration Certificate No.: 20163461824). Zimmer Medical (Shanghai) International Trading Co., Ltd., the responsible unit in China, reported on December 23, 2016, that the manufacturer identified a higher-than-expected crushing rate in titanium alloy humeral components produced before September 2011. This product quality issue prompted the recall. While the recall is global, Biomet Orthopedics confirmed that the specific affected batches were not distributed or sold within the Chinese market, and no related complaints have been reported in China. Under the NMPA's regulatory framework, provincial and municipal food and drug administrations are required to enhance their supervision and management concerning this issue. Products manufactured after September 2011 have undergone redesigns to improve their strength, addressing the identified flaw. This proactive measure highlights the company's commitment to maintaining product safety standards internationally.