China NMPA Product Recall - Unicompartmental knee joint system components

The National Medical Products Administration (NMPA) issued a recall notice on May 17, 2017, concerning Biomet UK LTD.'s Unicompartment Knee Joint System Components, specifically the Oxford unicompartment knee joint non-cemented tibial type. This voluntary global recall by Biomet UK LTD. was prompted by reports of tibial plateau fractures in patients, with a complaint analysis identifying a 0.12% incidence rate worldwide. The issue was attributed to the critical importance of proper surgical techniques, rather than a product defect, emphasizing adherence to product instructions for use. Zimmer Medical (Shanghai) International Trading Co., Ltd., the Chinese distributor, reported the issue to the NMPA. While the specific recalled batches were not sold within China, the NMPA requested all provincial, autonomous region, and municipality Food and Drug Administrations to strengthen supervision and management of similar medical devices. Biomet UK LTD. initiated field safety notification measures globally to highlight the necessity of correct surgical application to mitigate risks. No domestic adverse events or complaints have been recorded in China related to this product.