China NMPA Product Recall - Loop fixing plate system

Biomet Sports Medicine, the manufacturer of the Looped Fixation Plate System, has initiated a voluntary Class III recall of its product. This action was reported by Zimmer Medical (Shanghai) International Medical Trading Co., Ltd. The primary issue identified leading to this recall is the absence of a crucial black fixation plate component within the product packaging. This deficiency could potentially impact the intended functionality and safety of the medical device. The recall is conducted under the oversight of the National Medical Products Administration (NMPA), China's key regulatory authority for medical products, as indicated by the NMPA's publication of the recall notice on September 29, 2025. While a specific inspection date is not mentioned in the provided document, the required action by the company is the voluntary withdrawal of affected products from the market. It is important to note that, despite the manufacturer being Biomet Sports Medicine, the specific batches of the Looped Fixation Plate System involved in this Class III recall were explicitly stated as not having been imported into China, mitigating direct public health risk within the Chinese market. Detailed information on specific models and batches is available in the 'Medical Device Catalog' and the company's recall report form.