# China NMPA Product Recall - Intramedullary nail surgical tools

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-trauma/14ac83b7-eb5c-4b5d-9365-8a12509c0fb7/
Source feed: China

> China NMPA product recall for Intramedullary nail surgical tools by Biomet Trauma published September 09, 2016. Recall level: . The National Medical Products Administration (NMPA) issued a notice regarding a voluntary recall ini

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet Trauma recalls intramedullary nailing surgical tools.
- Company Name: Biomet Trauma
- Publication Date: 2016-09-09
- Product Name: Intramedullary nail surgical tools
- Recall Reason: Because the new version of the reconstruction soft tissue cannula is incompatible with the old version of the reconstruction anchoring arm, there may be situations where the old and new versions of the reconstruction soft tissue cannula and reconstruction anchoring arm are not compatible. When the old version of the reconstruction soft tissue cannula is used with the new reconstruction anchoring arm, there will be too much gap, which may prevent the surgeon from performing the surgery precisely, leading to surgical delays.
- Discovering Company: Bangmei (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Biomet Trauma
- Summary: The National Medical Products Administration (NMPA) issued a notice regarding a voluntary recall initiated by Biomet Trauma for specific batches of its intramedullary nail surgical tools. The recall targets reconstruction soft tissue cannulas (Model 14-442008, batches 76428, 2095181) and reconstruction anchoring arms (Model 14-442018, batches 290610, 290620, 386780). The primary issue identified is an incompatibility between the new version of the reconstruction soft tissue cannula and the old version of the anchoring arm. This mismatch results in an excessive gap during use, which can prevent surgeons from performing precise operations and potentially lead to surgical delays. The regulatory framework overseeing this action is the NMPA (formerly CFDA), which published the recall details and supervises medical device safety in China. While Biomet Trauma (Shanghai) Trading Co., Ltd. distributes these products, the affected batches were not sold in China, and no related complaints have been recorded domestically. However, the NMPA requested all provincial and municipal food and drug administrations to enhance their oversight and management of similar products to prevent future issues and ensure regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/biomet-trauma/a2c5e00c-de11-42fe-8d35-71deb78ef9d9/