China NMPA Product Recall - Distal tibial clip

Biomet (Shanghai) Trading Co., Ltd., the China-based responsible unit for manufacturer Biomet Trauma LLC, initiated a voluntary Class III recall for its Distal Tibial Clip, Model 816301006. This action, reported on October 23, 2015, and subsequently published by the National Medical Products Administration (NMPA) on December 9, 2015, stemmed from an internal company investigation. The investigation revealed a critical issue: the product was assembled with an incorrect clamping arm component, which could impact its intended use in general trauma surgery for guide pin clamping or surgical bone repositioning.The recall involves 66 units globally, with 10 units having been sold in China. Affected territories include Japan, Australia, China, Italy, Spain, New Zealand, South Africa, and the United Kingdom. The regulatory framework under the NMPA mandates clear corrective actions. Biomet (Shanghai) Trading Co., Ltd. is required to isolate all affected products, identifiable by specific batch numbers such as 072524 and 088526, and ensure their prompt return to the manufacturer, Biomet Trauma LLC.