China NMPA Product Recall - Longitudinal thoracic shaping artificial titanium rib system

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., on behalf of manufacturer Synthes GmbH, initiated a voluntary Class II recall of its Longitudinal Thoracic Reconstruction Artificial Titanium Rib System (Synthes). The recall, reported to the National Medical Products Administration (NMPA) in October 2015 based on a September 2015 company report, resulted from the discovery of a manufacturing defect. The issue involves a partially formed final hole in the product’s extension structure, which could lead to mechanical failure and breakage of the extension rod. This defect carries a risk of serious patient injury, including the need for additional surgical intervention, pain, loss of deformity correction, and potential damage to soft tissues or internal organs. Globally, eight complaints of extension rod breakage have been recorded since 2004, though none were directly attributed to this specific 'partially formed hole' defect, and no related complaints or adverse effects have been reported in China. The regulatory framework for this action falls under the NMPA's medical device recall guidelines. Required actions include notifying affected customers to cease use and manage the products appropriately. In China, 18 affected units were identified, with 3 sold, 8 in inventory, and 7 already destroyed; all remaining affected products are slated for local destruction.