China NMPA Product Recall - Locking bone screws

The National Medical Products Administration (NMPA) reported on July 30, 2013, a series of voluntary overseas recalls initiated by Synthes GmbH, with reporting facilitated by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. These recalls pertain to two distinct types of locking bone screws, both registered with the Chinese regulatory authority but not imported or sold within China. The first recall involves locking bone screws (Registration No. CFDA (Imported) No.: 3462425 (Updated)), where the primary issue was incorrect product packaging; specifically, 27mm screws were erroneously packaged in 2.4mm containers, and vice versa. Affected regions included Switzerland, Spain, the United Kingdom, Norway, Sweden, Australia, Colombia, and the United States. The second recall concerns locking bone plate screws (Registration No. SFDA(I)20103462425 (Revised)). For this product, a label printing error was identified, indicating a length of 50mm when the actual product length was 55mm. This recall impacted France, the United Kingdom, and Australia. Under the guidance of the NMPA, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. formally notified the State Food and Drug Administration of these incidents. Given that no units of the recalled products were imported into China, no direct recall actions were required or implemented within the country. However, Chinese provincial and municipal food and drug administrations were instructed to enhance their supervision and management of similar medical devices to safeguard public health and maintain regulatory compliance.