China NMPA Product Recall - Hollow nail system

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., on behalf of manufacturer Synthes GmbH, initiated a voluntary Level 2 recall for a specific batch of its Hollow Nail System. The recall was reported to the National Medical Products Administration (NMPA) on October 11, 2018, with public notification on November 6, 2018. The core issue was an error in product labeling for the 3.0mm hollow nail (Model 04.226.118, Batch L734474). Labels incorrectly indicated a 6mm thread length, describing them as "long-thread screws," when the actual product featured a 4mm thread length, qualifying them as "short-thread screws." This discrepancy in product identification could potentially affect proper surgical application for internal fixation of fractures.

Operating under the NMPA's regulatory framework, the company submitted a Medical Device Recall Event Report Form. However, since the identified batch had not been imported into China, and no units were distributed domestically, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. stated that no further corrective actions, investigations, or reports beyond the initial NMPA notification would be undertaken in China. The primary affected region for product distribution was noted as the USA.