China NMPA Product Recall - Locking plate

The National Medical Products Administration (NMPA) published a recall notice on April 13, 2016, regarding Locking Bone Plates manufactured by Synthes GmbH, a subsidiary of Johnson & Johnson. The recall, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on March 24, 2016, was initiated due to incorrect model labeling on the affected products (Registration Certificate No.: 20163460077). The primary issue identified was that certain Locking Bone Plates (models 04.115.150, 04.115.151, batch numbers 9678747, 9678750), intended for internal fixation of distal radius fractures, may have been etched with an incorrect product model number, such as a right-angled plate being labeled as a left-angled one. This mislabeling could potentially lead to discovery before or during surgery, causing surgical delays if a replacement plate is needed.

Under the NMPA's regulatory framework, provincial, autonomous region, and municipal food and drug administrations were requested to strengthen supervision of such medical devices. Crucially, the document explicitly states that none of the affected products were imported into or sold within China. Therefore, no specific corrective actions were required from Synthes GmbH or Johnson & Johnson within the Chinese market, though the recall did affect regions like Australia, Singapore, UAE, Czech Republic, and Germany.