China NMPA Product Recall - Pneumatic drill (product name: Little King Kong)

Synthes GmbH initiated a voluntary overseas recall for its pneumatic grinding drill (models Micromax and Xmax, also known as King Kong or Xiaojin). The recall, reported to China's National Medical Products Administration (NMPA) by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. in May 2013, addresses a critical safety issue. The main concern is the unexpected rupture of the drill’s external hose when airflow is obstructed during surgical use. This defect impacts all drilling system hose assemblies manufactured before May 13, 2009, when a design change incorporated a pressure relief valve to mitigate this risk. Despite the product having an existing CFDA (now NMPA) registration in China, the company confirmed that no affected units were imported into or sold within the country. Consequently, while the NMPA encourages enhanced supervision by local departments, no direct recall actions are required in China. This report serves to inform the Chinese regulatory body of the international recall and affirm that Chinese patients or healthcare providers are not impacted by this specific product issue. The recall covers numerous countries across Europe, the Middle East, Africa, and the Americas.