# China NMPA Product Recall - Distal tibial clip

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-trauma/63a1e2a2-8835-42a1-9a75-7292eba00b2c
Source feed: China

> China NMPA product recall for Distal tibial clip by Biomet Trauma published December 09, 2015. Recall level: Level III. On December 9, 2015, the National Medical Products Administration (NMPA) announced a voluntary Class

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bonmei (Shanghai) Trading Co., Ltd. voluntarily recalls distal tibial clips
- Company Name: Biomet Trauma
- Publication Date: 2015-12-09
- Product Name: Distal tibial clip
- Recall Level: Level III
- Recall Reason: An internal company investigation revealed that the product was assembled with incorrect clamping arm components.
- Discovering Company: Bangmei (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Biomet Trauma
- Summary: On December 9, 2015, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Bangmei (Shanghai) Trading Co., Ltd. for the Distal Tibial Clip. The manufacturer, Biomet Trauma LLC, was identified as the origin of the product. An internal company investigation, reported on October 23, 2015, revealed a significant product defect: the Distal Tibial Clip (model 816301006, batch numbers including 072524, 072525, 088526, and OL7434) was incorrectly assembled with an improper clamping arm component. This medical device is designed for general trauma surgery, used for clamping guide pins or repositioning surgical bones. The recall impacts 66 units globally, with 10 units sold within China, and extends to countries such as Japan, Australia, Italy, Spain, New Zealand, South Africa, and the United Kingdom. Under the NMPA's regulatory framework, Bangmei (Shanghai) Trading Co., Ltd. mandated that all affected products be isolated and returned to the manufacturer, Biomet Trauma LLC, to ensure patient safety and product integrity.

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