# China NMPA Product Recall - Locking metal plate system

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-trauma/1304af4e-0955-48c4-a6d6-0a12e5ce8e17/
Source feed: China

> China NMPA product recall for Locking metal plate system by Biomet Trauma published November 23, 2017. Recall level: Level 2 Recall. Biomet Trauma, a medical device manufacturer, initiated a voluntary Class II recall of its locking m

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet Trauma initiates voluntary recall of its locking metal plate system.
- Company Name: Biomet Trauma
- Publication Date: 2017-11-23
- Product Name: Locking metal plate system
- Recall Level: Level 2 Recall
- Recall Reason: Using incorrect F.A.S.T. indicator colors during production can make it difficult to identify drill bit size and drilling direction.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Biomet Trauma
- Summary: Biomet Trauma, a medical device manufacturer, initiated a voluntary Class II recall of its locking metal bone plate system. This action was reported by Zimmer Medical (Shanghai) International Trading Co., Ltd. on November 23, 2017, following a recall event report dated November 22, 2017. The core issue stemmed from the use of incorrect F.A.S.T. indicator colors during the product's manufacturing. This defect could lead to significant challenges for medical professionals in accurately identifying the correct drill bit size and drilling direction during surgical procedures, posing potential risks to patient safety and surgical efficacy. The recall is being managed under the regulatory oversight of the National Medical Products Administration (NMPA) in China. The primary required action involves the prompt voluntary removal of the affected locking metal bone plate systems from circulation. Comprehensive details, including specific product models, specifications, and batch numbers impacted by this recall, are documented in the associated Medical Device Recall Event Report Form.

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