China NMPA Product Recall - Inverted shoulder joint system

Biomet Orthopedics, through its Chinese responsible unit Zimmer Medical (Shanghai) International Trading Co., Ltd., initiated a voluntary global recall for its Inverted Shoulder Joint System. This action, reported to the National Medical Products Administration (NMPA) on December 23, 2016, and published on February 21, 2017, addresses a critical quality concern. The primary issue identified was a potentially higher-than-expected crushing rate in the titanium alloy humeral girders manufactured before September 2011.

In response to this finding, Biomet Orthopedics redesigned all subsequent products, with those manufactured after September 2011 featuring enhanced strength. Notably, the company confirmed that the specific affected batches were not sold within the Chinese market, and no related complaints have been received in China. Under its regulatory framework for medical devices, the NMPA has nonetheless instructed provincial, autonomous region, and municipal food and drug administrations to reinforce their supervision and management efforts concerning this matter, ensuring continuous vigilance over product safety.