China NMPA Product Recall - Locking bone screws

On November 17, 2020, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall for a specific batch of its locking bone screws (batch number 04.130.310/5L82113). The recall was prompted by the discovery that the apex diameter of these screws did not meet the registered product standard, as reported by the company to the National Medical Products Administration (NMPA). Despite this discrepancy with the registered standard, Synthes, the manufacturer, confirmed that the product adheres to their internal quality standards, including the apex diameter quality specification. The company stated that, when used according to its intended instructions, the product is not anticipated to cause any risk to its performance or patient safety. No adverse events associated with this particular batch have been reported in China to date. Operating under the oversight of the NMPA, this voluntary action is classified as a Class III recall. This classification typically signifies situations where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is actively recalling the affected medical devices to ensure full compliance with regulatory expectations, even though the immediate risk to patients is deemed low.