China NMPA Product Recall - Artificial cervical intervertebral disc (trade name: Mobi-C)

Zimmer Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall of its Artificial Cervical Intervertebral Disc, marketed under the trade name Mobi-C. Announced on January 11, 2019, this action was taken due to a significant labeling error: the product's height was incorrectly specified on its label. This recall pertains to devices with Registration Certificate No.: NMPA Medical Device (Imported) 2013 No. 3463751 (Revised). The company reported this issue and executed the recall under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, which initially issued the medical device registration certificate. Detailed information regarding the specific models, specifications, and affected batches is available in the "Medical Device Recall Event Report Form" attachment. This proactive measure by Zimmer Medical aims to address the labeling discrepancy and ensure the accurate identification and use of its medical devices, maintaining compliance with established regulatory standards for medical device labeling and safety.