China NMPA Product Recall - Inverted shoulder joint system

Biomet Orthopedics, through Zimmer Medical (Shanghai) International Trading Co., Ltd., initiated a voluntary Class II recall of its inverted shoulder joint system (Registration Certificate No.: 20163461824) on September 17, 2020. The recall was prompted by identified manufacturing issues, specifically assembly errors and incorrect quantities of shoulder caps and adapters within certain product models and batches. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA) in China, which published the notice on September 18, 2020. The required action is the complete recall of the affected medical devices to address these critical defects, with detailed information available in the "Medical Device Recall Event Report Form" attachment. This proactive measure ensures patient safety and product integrity by removing non-conforming products from distribution.