# China NMPA Product Recall - Locking metal plate systems DVR and F3 Plate Systems

Source: https://www.globalkeysolutions.net/records/china_product_recall/bonmei-trauma-company/3f35dceb-59bd-4608-818b-8df80c93eb11/
Source feed: China

> China NMPA product recall for Locking metal plate systems DVR and F3 Plate Systems by Bonmei Trauma Company published June 17, 2022. Recall level: Level 3 Recall. Zimmer Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class III recall for

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet Trauma Corporation is voluntarily recalling its DVR and F3 Plate Systems locking metal plate systems.
- Company Name: Bonmei Trauma Company
- Publication Date: 2022-06-17
- Product Name: Locking metal plate systems DVR and F3 Plate Systems
- Recall Level: Level 3 Recall
- Recall Reason: There is an issue where incorrectly labeled DVRASL boards are mistakenly identified as DVRAAR or DVRASR.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Bonmei Trauma Company
- Summary: Zimmer Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class III recall for specific batches of Biomet Trauma’s Locking Metal Plate Systems, including the DVR and F3 Plate Systems. This action, reported on June 16, 2022, and published by the National Medical Products Administration (NMPA) on June 17, 2022, addresses a critical labeling error. The issue involves DVRASL plates being incorrectly marked and subsequently used as DVRAR or DVRASR plates. The recall targets products with Registration Certificate No.: 20183132302. While the document does not detail specific inspection dates, the prompt reporting by Zimmer Medical indicates proactive quality control measures or discovery. Under the NMPA's regulatory oversight, the manufacturer, Biomet Trauma, is responsible for this recall. A Class III recall signifies that exposure to the affected product is unlikely to cause adverse health consequences. The immediate required action involves the voluntary removal of the affected products from the market. Comprehensive details regarding the precise models, specifications, and batch numbers impacted by this recall are provided in an attached "Medical Device Recall Event Report Form," ensuring that distributors and healthcare providers can accurately identify and manage the recalled devices. This action underscores the importance of accurate product labeling for patient safety within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/bonmei-trauma-company/88fd6829-efae-46f4-847c-0cad3060e16b/