China NMPA Product Recall - Knee prosthesis - High flexion tibial pad component

Zimmer Medical (Shanghai) International Trading Co., Ltd., a subsidiary of Zimmer Inc., initiated a voluntary Level 3 recall for its "high-flexibility knee prostheses," specifically the Curvature Tibial Liner Component (Part Number 00-5960-030-12, Batch Number 62397901). The recall, initially reported to the Shanghai Food and Drug Administration in December 2014, was prompted by the product's dimensions not conforming to established product standard claims. On January 13, 2015, Zimmer Medical (Shanghai) issued a correction to the Shanghai FDA, clarifying that an internal system error had resulted in an incorrect recall quantity in their initial report. The revised figures indicated that 43 units of the affected product were imported into China, with 26 units having been sold. Under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, the company's required action was to return all affected products to Zimmer Biomet. This incident highlights the company's adherence to regulatory processes for addressing product discrepancies and maintaining device quality within the Chinese market.