# China NMPA Product Recall - Dental Abutment

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-3i/a0553f20-86c6-48eb-bf8d-7c3e711ac513/
Source feed: China

> China NMPA product recall for Dental Abutment by Biomet 3i published January 19, 2020. Recall level: Level 3 Recall. Biomet (Shanghai) Medical Device Co., Ltd. has initiated a voluntary Class III recall for its Biomet

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Jiemei (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling Dental Abutments.
- Company Name: Biomet 3i
- Publication Date: 2020-01-19
- Product Name: Dental Abutment
- Recall Level: Level 3 Recall
- Recall Reason: Imprint or scan data generated by the batch of abutments can lead to problems such as the final abutment being incorrectly rotated by approximately 30 degrees and/or misalignment of edge contours.
- Discovering Company: Jiemei (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Biomet 3i
- Summary: Biomet (Shanghai) Medical Device Co., Ltd. has initiated a voluntary Class III recall for its Biomet 3i Dental Abutments (Registration Certificate No.: 20183631566). This action was publicly announced by the National Medical Products Administration (NMPA) on January 19, 2020, with further publication details on February 8, 2020. The recall addresses critical quality issues observed in specific batches of the dental abutments. The main violations involve the generation of inaccurate impressions or scan data, leading to an incorrect rotational alignment of approximately 30 degrees and/or misalignment of edge contours. These manufacturing defects pose a risk to the proper seating and long-term functionality of dental prosthetics. Operating under the regulatory oversight of the NMPA, Biomet (Shanghai) Medical Device Co., Ltd. is required to voluntarily recall the affected products from the market to mitigate potential harm to patients and ensure compliance with medical device standards. The "Medical Device Recall Event Report Form" contains comprehensive information regarding the specific product models, specifications, and batch numbers implicated in this recall, underscoring the company's commitment to addressing product deficiencies and upholding patient safety.

Company: https://www.globalkeysolutions.net/companies/biomet-3i/6baafc65-20b1-4930-9b03-4bcb90c176f6/