China NMPA Product Recall - Multi-hole acetabular cup

On January 7, 2015, the National Medical Products Administration (NMPA) issued a recall notice concerning Zimmer Inc., Inc., an American medical device manufacturer. This action followed a report received on December 22, 2014, from Zimmer (Shanghai) Medical International Trading Co., Ltd. The primary issue involved multi-hole acetabular cups (CFDA (Imported) No. 20113461), specifically the 54mm porous acetabular cups with batch number 62714305, which were found to have potentially missing internal threads. This defect could impede the proper attachment of surgical screws, leading to potential delays during hip surgery procedures. Operating under the regulatory framework of the NMPA (formerly CFDA in China), Zimmer Inc. initiated a voluntary global recall of the affected product batch. The company confirmed that these specific recalled products were not sold or imported into the Chinese market. As a corrective action, all affected products globally are to be returned to Zimmer Inc. The NMPA additionally requested that relevant provincial, autonomous region, and municipal food and drug administration departments supervise and manage this product within their jurisdictions, underscoring a commitment to patient safety and quality control.