# China NMPA Product Recall - Dental implant system

Source: https://www.keypedia.com/records/china_product_recall/nobel-biocare-ab/66ab7cf6-0936-4c96-ab6c-8985c0971a77
Source feed: China

> China NMPA product recall for Dental implant system by Nobel Biocare AB published August 09, 2019. Recall level: Level 2. Nobel Biocare Trading (Shanghai) Co., Ltd. announced a voluntary Class II recall of dental implant s

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nobel Biocare AB initiates voluntary recall of dental implant systems.
- Company Name: Nobel Biocare AB
- Publication Date: 2019-08-09
- Product Name: Dental implant system
- Recall Level: Level 2
- Recall Reason: The products in question may have labels indicating incorrect product dimensions.
- Discovering Company: Nobocom Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Nobel Biocare AB
- Summary: Nobel Biocare Trading (Shanghai) Co., Ltd. announced a voluntary Class II recall of dental implant systems manufactured by its parent company, Nobel Biocare AB. This action, reported to the National Medical Products Administration (NMPA) and published on August 9, 2019, was initiated due to a potential issue involving the incorrect labeling of product dimensions. The NMPA document (Index No.: JGXX-2019-10516) indicates that the manufacturer identified discrepancies in the stated specifications of the dental implant systems. While specific models, specifications, and batches are detailed in an attached 'Medical Device Recall Event Report Form,' the overarching concern is to ensure precise and accurate product information. The Class II recall classification signifies that the incorrect labeling could potentially lead to temporary or medically reversible adverse health consequences, or that the likelihood of serious adverse health consequences is remote. This proactive measure by Nobel Biocare AB underscores their commitment to regulatory compliance and patient safety in the medical device sector, emphasizing the critical importance of accurate product information for healthcare professionals and patients.

Company: https://www.keypedia.com/companies/nobel-biocare-ab/2db6dd94-999f-409e-b9db-d1834ae48604