# China NMPA Product Recall - Nobel Procera Dental Ceramics

Source: https://www.globalkeysolutions.net/records/china_product_recall/nobel-biocare-ab/92d08177-e263-42a1-882d-315ec185142f
Source feed: China

> China NMPA product recall for Nobel Procera Dental Ceramics by Nobel Biocare AB published June 30, 2021. Recall level: Level 2 Recall. Nobel Biocare AB, in collaboration with Nobel Biocare Trading (Shanghai) Co., Ltd., has initiated a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nobel Biocare AB initiates voluntary recall of Nobel Procera Dental Ceramics dental ceramics.
- Company Name: Nobel Biocare AB
- Publication Date: 2021-06-30
- Product Name: Nobel Procera Dental Ceramics
- Recall Level: Level 2 Recall
- Recall Reason: In March 2021, a sintering furnace used in production failed to achieve a suitable sintering profile.
- Discovering Company: Nobocom Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Nobel Biocare AB
- Summary: Nobel Biocare AB, in collaboration with Nobel Biocare Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall for specific models and batches of its Nobel Procera Dental Ceramics. This action, reported to the National Medical Products Administration (NMPA) on June 30, 2021, originates from a manufacturing issue identified in March 2021. The primary concern is a sintering furnace malfunction during production, which prevented certain products from achieving the required sintering curve. This deviation could potentially compromise the quality and performance of the affected dental ceramics. The recall targets products covered by Registration Certificate No.: 20162635088, with detailed information on specific models and batches available in the "Medical Device Report Form." This proactive measure reflects Nobel Biocare AB's commitment to product safety and adherence to NMPA regulatory standards, ensuring the removal of non-conforming products from the market to protect patient health.

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