China NMPA Product Recall - Intramedullary nail system

Synthes GmbH initiated a voluntary recall of a specific batch of its intramedullary nail system, a medical device for internal fixation of long bone fractures, as documented in a National Medical Products Administration (NMPA) notice published on December 10, 2015. The recall report, submitted by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on October 26, 2015, detailed the primary issue: excessively large thread outer and inner diameters on certain hip screws. This manufacturing flaw could prevent the hip screws from properly passing through the opening of the proximal femoral intramedullary nail during surgical procedures. Such a malfunction would lead to significant surgical delays or potentially require the termination of the operation, necessitating a subsequent reoperation with suitable components. Critically, Johnson & Johnson confirmed that the affected product batch was neither imported nor sold within China. Therefore, under the NMPA's regulatory framework, while the recall was reported, no further corrective actions, investigation, or implementation plans were deemed necessary for the Chinese market. Regional food and drug administrations were, however, instructed to strengthen supervision over similar medical products. The recall affected other regions, including Austria, Italy, Kenya, and Taiwan.