China NMPA Product Recall - Spinal internal fixation system

The National Medical Products Administration (NMPA) issued a Level III voluntary recall notification (Index No. JGXX-2018-11239) on October 22, 2018, regarding a spinal internal fixation system. The recall was initiated by Medtronic Sofamor Danek USA, Inc., with Medtronic (Shanghai) Management Co., Ltd. reporting the issue on September 11, 2018. The primary concern was a labeling discrepancy for a specific 5.0x45 universal screw (Model 55840005045, Batch 0648247W). The product's packaging indicated "5.0mm X 45mm," while the laser marking directly on the screw head displayed "5.5 X 45," representing a potential for product misidentification. This recall was categorized as Class III due to the nature of the issue. Importantly, the affected products were exclusively designated for sale in the United States and were not distributed within China. As a result, Medtronic (Shanghai) Management Co., Ltd. confirmed that no corrective actions or further measures were necessary in China, as no recalled inventory entered the Chinese market.