# China NMPA Product Recall - Unicompartmental knee joint system components

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-uk-ltd/148e2fab-d19b-4d9e-b253-0d2a15d5ca27/
Source feed: China

> China NMPA product recall for Unicompartmental knee joint system components by Biomet UK LTD. published May 17, 2017. Recall level: . Biomet UK LTD., in conjunction with its distributor Zimmer Medical (Shanghai) International Medical 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet UK LTD. is recalling components of its unicompartmental knee system.
- Company Name: Biomet UK LTD.
- Publication Date: 2017-05-17
- Product Name: Unicompartmental knee joint system components
- Recall Reason: The patient developed a tibial plateau fracture. The investigation revealed that the importance of appropriate surgical techniques in certain procedures was not adequately emphasized, increasing the risk of tibial plateau fractures.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Biomet UK LTD.
- Summary: Biomet UK LTD., in conjunction with its distributor Zimmer Medical (Shanghai) International Medical Trading Co., Ltd., initiated a voluntary global recall for specific components of its Oxford Unicompartment Knee Joint System, notably the uncemented tibial type. This regulatory action, documented under National Medical Products Administration (NMPA) Index No. JGXX-2017-10407, was reported around May 2017. The primary concern arose from patient reports of tibial plateau fractures, with a worldwide incidence of 0.12%. Investigations confirmed that the product met design specifications, attributing the fractures primarily to the critical importance of adherence to specific surgical techniques and the product's instructions for use. While a global field safety notification was enacted, Biomet UK LTD. verified that the affected product batches were not distributed or sold within China, and consequently, no domestic adverse events or complaints have been recorded. The NMPA instructed provincial Food and Drug Administrations to enhance supervision over similar medical devices. The required action emphasizes strict compliance with established surgical protocols and product guidelines to minimize risks and ensure patient safety.

Company: https://www.globalkeysolutions.net/companies/biomet-uk-ltd/750d81e3-7769-4941-8a3b-cd9c3a417d61/