# China NMPA Product Recall - Unicompartmental knee joint system components

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-uk-ltd/2f7a00ac-654d-48b0-a7b2-f71dacee8239/
Source feed: China

> China NMPA product recall for Unicompartmental knee joint system components by Biomet UK LTD. published May 17, 2017. Recall level: . The National Medical Products Administration (NMPA) issued notice JGXX-2017-10410 concerning a globa

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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: In light of trends in reported tibial plateau fractures, complaint analysis found that 0.12% of patients worldwide experience a tibial plateau fracture. The Oxford unicompartment uncemented tibial component for the knee has been manufactured to design specifications. Investigations into the causes of tibial plateau fractures have revealed the importance of appropriate surgical techniques described in certain procedures to reduce the risk of tibial plateau fractures. Biomet UK Ltd, through this notification, emphasizes the importance of adhering to appropriate surgical techniques and the contents of the product's accompanying instructions.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Biomet UK LTD.
- Summary: The National Medical Products Administration (NMPA) issued notice JGXX-2017-10410 concerning a global voluntary recall initiated by Biomet UK LTD. for its Oxford unicompartment knee joint uncemented tibial components (NMPA Registration Certificate No.: 20163462135). Zimmer Medical (Shanghai) International Medical Trading Co., Ltd. distributes these products in China. The primary issue identified is a 0.12% worldwide incidence of tibial plateau fractures in patients. Investigations determined that while the product's design met specifications, the fractures are attributed to the critical importance of surgical techniques and strict adherence to the product's accompanying instructions. Although the affected product batches were not sold in China and no domestic adverse events were reported, the NMPA requested all provincial Food and Drug Administrations to enhance supervision of similar medical devices. Biomet UK LTD. is implementing field safety notification measures to reinforce correct surgical procedures and proper use, thereby mitigating potential risks and ensuring patient safety.

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