China NMPA Product Recall - Locking plate

The National Medical Products Administration (NMPA) issued a recall notice on June 5, 2014, regarding locking bone plates manufactured by Synthes GmbH, Switzerland, and distributed in China by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall, reported on June 3, 2014, was voluntarily initiated by Synthes GmbH due to an issue with incorrect product packaging. Specifically, the first line of text on the product label for model 224.838S was inconsistent with its multilingual text.

Despite the product being registered in China, the manufacturer confirmed that no affected batches of these locking bone plates were sold, imported, or distributed within the Chinese market. Consequently, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. informed the NMPA that no further investigation, evaluation, implementation, or summary reports would be submitted, as the recall did not directly impact China. The NMPA, however, advised food and drug administrations across all provinces, autonomous regions, and municipalities to strengthen their supervision over this type of medical device. The recall primarily affected regions including Switzerland, Germany, Denmark, France, the United Kingdom, Iran, Sweden, and Australia, highlighting the global reach of such regulatory actions.