China NMPA Product Recall - Locking bone screws

The National Medical Products Administration (NMPA) issued a recall notice on December 21, 2015, concerning locking bone screws manufactured by Synthes GmbH and distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. This voluntary recall, initially reported on November 15, 2015, addresses potentially incorrect packaging instructions for certain batches of variable angle locking screws (e.g., GP2613). The primary violation stems from instructions intended for a different product (GP26150) being included with the affected screws. This discrepancy poses a risk that users might not follow the correct technical guidelines, leading to variable-angle screws failing to lock securely, which could cause surgical delays. More critically, improper use might damage the epiphyseal plate in adolescent patients, potentially resulting in conditions such as malunion or nonunion. While there is a noticeable color difference between the screw types, the incorrect instructions present a significant safety concern. This recall, operating under the NMPA's regulatory framework (formerly CFDA), primarily affects products sold in the USA and Canada. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. confirmed that the recalled products were not imported into China. Consequently, no direct corrective actions are required for products within China. However, Chinese provincial food and drug administrations are directed to strengthen their oversight and management of similar medical devices.