China NMPA Product Recall - Trial

The National Medical Products Administration (NMPA) published a notice on July 13, 2015, regarding a voluntary recall initiated by DePuy Ireland for its Trial Molding Device (Registration No.: 20150658). Distributed in China by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the recall addresses a critical safety issue: the potential damage and detachment of Balsalin, a small steel wire spring coil, from the device's post during orthopedic surgery. The primary concern is that a detached Balsalin could enter the surgical site and potentially remain inside a patient, as occurred in one international case requiring secondary surgery. The reported incidence of detachment is 0.065%, with patient retention at 0.002%. Operating under the NMPA's regulatory framework, Johnson & Johnson (Shanghai) reported this global safety concern. Crucially, the affected product was not imported or sold in China. Therefore, the company's required actions in China were limited to reporting the issue to the NMPA, with no further investigations or implementation plans deemed necessary for the Chinese market. The NMPA, in turn, requested provincial and municipal food and drug administrations to enhance supervision of similar products.