China NMPA Product Recall - Hip prosthesis-acetabular system

On August 5, 2019, Zimmer Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall concerning specific batches of its hip prostheses, specifically Allofit-S acetabular cups with perforations. This action was prompted by a manufacturing issue: the potential for mixed batches of sizes 52/II and 54/JJ, which could lead to incorrect product being supplied. The affected products were registered under certificate number 20173466495. This recall was conducted under the regulatory framework of China's National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. A Class II recall indicates that the product defect could lead to temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The required action for the company involved submitting a "Medical Device Recall Event Report Form," which provided detailed information on the specific product models, specifications, and batch numbers implicated in this event, ensuring comprehensive documentation and management of the recall process.