China NMPA Product Recall - Spinal surgical implants - anterior cervical locking plate screws

On December 22, 2014, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting under the oversight of China's National Medical Products Administration (NMPA), initiated a voluntary Class II recall. The recall, impacting products manufactured by Synthes GmbH, concerned specific Anterior Cervical Locking Plate Screws used in spinal surgery implants. The core issue involved a manufacturing discrepancy for 4.0mm TI cortical bone expansion head screws (specification 450.138, batch number 8395713). It was discovered that these screws, intended to be 14mm, were incorrectly manufactured at 16mm, and their pitch and thread geometry did not conform to the specified product drawing but rather matched a different product (450.133). Additionally, a color inconsistency indicated a mix-up prior to the anodizing process. The use of these defective devices posed potential risks, including bone, soft tissue, or spinal cord injury, and could lead to surgical delays. Fortunately, only one complaint was received, and the error was identified pre-operatively, preventing any patient harm or surgical delay. The recall specifically targeted 40 units of model/specification 450.138, batch number 8395713, which had been imported and sold in China. Affected screws could be visually distinguished by their incorrect thread shape or by protruding from their designated screw holder.