# China NMPA Product Recall - Knee joint surgical tools

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-uk-limited/6de3fb2b-2a49-4f01-bee4-5d8c7eecd9ca/
Source feed: China

> China NMPA product recall for Knee joint surgical tools by Biomet UK Limited published February 27, 2017. Recall level: . The National Medical Products Administration (NMPA) reported a voluntary global recall initiated by 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet UK Limited recalls knee surgery tools
- Company Name: Biomet UK Limited
- Publication Date: 2017-02-27
- Product Name: Knee joint surgical tools
- Recall Reason: The raw materials of the calibrated batch of knee surgical instruments may contain alumina, which could potentially cause product breakage.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Biomet UK Limited
- Summary: The National Medical Products Administration (NMPA) reported a voluntary global recall initiated by Biomet UK Limited, a medical device manufacturer, for specific batches of knee surgery tools. The recall was publicly announced on February 27, 2017, following a report submitted on January 10, 2017, by Zimmer Medical (Shanghai) International Trading Co., Ltd., the distributor in China. The primary issue identified was the potential presence of alumina in the raw materials used for these knee surgical instruments, which posed a risk of product breakage. These tools, registered under NMPA filing number 国械备20160498号, are designed for critical functions such as measuring diameter, depth, and angle, as well as for positioning and tissue protection during orthopedic surgery. Under the NMPA's regulatory oversight, Biomet UK Limited undertook this recall. Significantly, the affected batches were never sold within China, and no related adverse events or complaints have been reported in the country. Consequently, no specific corrective actions were required for products in the Chinese market. However, provincial and municipal food and drug administrations were advised to enhance their supervision of similar medical devices to ensure continued product safety and compliance.

Company: https://www.globalkeysolutions.net/companies/biomet-uk-limited/bad0cf22-37ea-453b-8c51-901d5eef5775/