# China NMPA Product Recall - Implant base and screws

Source: https://www.globalkeysolutions.net/records/china_product_recall/nobocom-trading-shanghai-co-ltd/209c8aea-1c5c-41c8-8cc8-1ace5e189395/
Source feed: China

> China NMPA product recall for Implant base and screws by Nobocom Trading (Shanghai) Co., Ltd. published August 12, 2019. Recall level: Level 2. On August 12, 2019, Novobio Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for s

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Novobio Trading (Shanghai) Co., Ltd. is voluntarily recalling implant abutments and screws.
- Company Name: Nobocom Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-08-12
- Product Name: Implant base and screws
- Recall Level: Level 2
- Recall Reason: The product may contain incorrect screws; assessments indicate this issue could cause the screws to loosen.
- Discovering Company: Nobocom Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Nobocom Trading (Shanghai) Co., Ltd.
- Summary: On August 12, 2019, Novobio Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for specific batches of its implant abutments and screws. This action was taken in accordance with the regulatory framework governed by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, as detailed in the medical device registration information. The decision to recall stemmed from a customer complaint originating in Japan, reporting incorrect screws packaged with an abutment product, specifically product number 36662, batch number 13078005. An internal investigation, conducted by Novopus, confirmed the validity of this complaint and subsequently identified a total of seven affected product batches. The primary issue identified was the potential for these incorrect screws to loosen when used as intended. This defect could compromise the stability and functionality of the dental implants, posing a risk to patients. As a required action, Novobio (Novopus) launched a voluntary recall to mitigate these potential risks. This proactive measure ensures the removal of all affected implant abutments and screws from circulation, upholding product safety and regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/nobocom-trading-shanghai-co-ltd/11653d1a-80e6-4ec5-be7b-9f79772942d0/