China NMPA Product Recall - Metal locking plate system

ZIMMER (Shanghai) Medical International Trading Co., Ltd. initiated a Class II voluntary recall for specific batches of its Metal Locking Bone Plate System, as reported to the National Medical Products Administration (NMPA) on March 24, 2015. The recall was prompted by a critical labeling error: the Chinese label for certain distal humeral medial locking plates incorrectly indicated the left side, while the original product label correctly specified the right side. This left-right reversal error affected product models 47-2358-107-15 and 47-2358-107-11, with 11 units and 7 units respectively imported and sold in China. Affected batch numbers include 61803307, 62084127, 61969598 for the 11-hole plate, and 61825319 for the 15-hole plate. The Metal Locking Bone Plate System is intended for temporary internal fixation and stabilization of bone around joints. As a corrective action, ZIMMER is recalling all affected products. This action underscores the importance of accurate product information to ensure patient safety in medical device usage.