China NMPA Product Recall - Bone-metal porous acetabular shell

On November 25, 2014, Zimmer (Shanghai) Medical International Trading Co., Ltd., acting for Zimmer Inc., initiated a voluntary global recall of specific porous metal acetabular shells. This action was reported to the National Medical Products Administration (NMPA) of China, the regulatory body overseeing medical devices. The core issue identified was the absence of internal threads in the top hole of the Continuum® Bone-Metal Porous Acetabular Shells. These threads are essential for connecting the shell with the prosthesis implant tool during surgery, though not for locking screws. The affected products, bearing Part Number 00-8757-068-02 and Batch Number 62207029, were registered under CFDA (Imported) 2012. Zimmer confirmed that no affected units were sold or imported into the Chinese market. As a corrective measure, all faulty products were returned to Zimmer Inc. The NMPA subsequently instructed all regional food and drug administrations to increase their supervision of similar medical devices to uphold product quality and patient safety.