China NMPA Product Recall - occipital-cervical-thoracic fusion system

B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall of its Occipitocervical-Thoracic Fusion System (Trade Name: S4) on July 13, 2020. The decision followed post-market surveillance where biomechanical testing by the manufacturer, Aesculap AG, revealed a decreased clamping force in the S4C transverse joint. This issue, while not leading to full separation, presents a risk of displacement at the connection with the occipital rod. The company has not received any adverse event reports related to this specific issue but is taking proactive measures to prevent potential patient risks. The recall is being conducted under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. Affected product models, specifications, and batches are detailed in the accompanying Medical Device Recall Event Report Form. The required action is a voluntary recall of the identified medical device to ensure patient safety.