China NMPA Product Recall - Locking metal plate system

Zimmer Medical (Shanghai) International Trading Co., Ltd. reported a Class II voluntary recall initiated by its manufacturer, Biomet Trauma, for its Locking Metal Bone Plate System (Registration Certificate No.: 20143465586). The recall, reported on October 31, 2017, and published by the National Medical Products Administration (NMPA) on November 23, 2017, addresses a manufacturing error where incorrect F.A.S.T. indicator colors were used on the A.P.L.S Locking Calcaneal Plate F.A.S.T Guide. Specifically, gold was used instead of the required magenta color. This color discrepancy could lead to difficulties in identifying the correct drill bit size and drilling direction during surgical procedures. However, the issue has been assessed and determined not to pose a risk of injury to patients. The affected product batch, identified as 989430, was not distributed or sold within China. Consequently, no direct corrective actions are required for the Chinese market. The recall primarily impacts regions including Chile, the Netherlands, and the USA, ensuring product safety and accurate medical device usage in affected international markets under NMPA oversight.