China NMPA Product Recall - Artificial hip joint components

The National Medical Products Administration (NMPA) announced a voluntary Level III recall on November 7, 2018, initiated by United Orthopedic Instruments Co., Ltd. The recall, detailed in a report dated October 23, 2018, concerns Artificial Hip Joint Components, specifically Titanium Alloy Cancellous Bone Screws (model 5206-1025, batch number 17B619DD). The core issue was a product labeling error where the item inside the packaging did not match the inner barcode label, although it was consistent with the outer box label. These components are intended for use in primary or secondary artificial hip replacement surgeries for various indications, including non-inflammatory and inflammatory joint diseases. The recall affects products distributed in the United States, Taiwan, Ukraine, Philippines, Indonesia, and Spain, with confirmation that no affected units were sold in China. Under NMPA regulatory requirements, United Orthopedic Instruments Co., Ltd. is mandated to issue recall notices to all affected customers, requesting the return of the specific product batch. All returned products are then required to undergo a thorough inspection at the factory to address and verify the labeling discrepancy.