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

In an action announced on October 29, 2019, Aesculap AG initiated a voluntary Class II recall of its Occipitocervicothoracic Fusion System. The recall was prompted by an issue identified by B. Braun Medical (Shanghai) International Trading Co., Ltd., concerning an incorrect orientation of the groove designed for fixing the occipital rod on the occipital plate. This manufacturing defect prevents the occipital rod from being properly inserted into the plate, compromising the intended functionality of the medical device. The recall specifically targets certain batches of the fusion system (Registration Certificate No.: 20173462025), which is manufactured by Howmedi Corp. The National Medical Products Administration (NMPA) of China oversees this regulatory action. A Class II recall indicates that the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Affected parties are directed to consult the "Medical Device Recall Event Report Form" for precise details regarding impacted product models, specifications, and batch numbers to facilitate appropriate actions.