# China NMPA Product Recall - Medical bone matrix induction

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-xiaobo-technology-development-co-ltd/05d04afc-f700-42d5-b397-e35a66bb4788/
Source feed: China

> China NMPA product recall for Medical bone matrix induction by Shanghai Xiaobo Technology Development Co., Ltd. published August 09, 2021. Recall level: Level 3 Recall. Shanghai Xiaobo Technology Development Co., Ltd. initiated a voluntary Class III recall of its Medic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Xiaobo Technology Development Co., Ltd. voluntarily recalls medical-grade bone-inducing matrix.
- Company Name: Shanghai Xiaobo Technology Development Co., Ltd.
- Publication Date: 2021-08-09
- Product Name: Medical bone matrix induction
- Recall Level: Level 3 Recall
- Recall Reason: The product registration number registered on the medical induced bone matrix production license has expired, and the new product registration number for renewal has not yet been registered. Therefore, it is necessary to proactively recall the products previously issued with the new registration number.
- Discovering Company: Shanghai Xiaobo Technology Development Co., Ltd.
- Manufacturing Company: Shanghai Xiaobo Technology Development Co., Ltd.
- Summary: Shanghai Xiaobo Technology Development Co., Ltd. initiated a voluntary Class III recall of its Medical Inducing Bone Matrix product, as reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on August 9, 2021. The recall stems from an administrative issue where the production license for the Medical Inducing Bone Matrix contained an expired product registration certificate number. Furthermore, the company had not secured a renewed product registration certificate number, despite the expiration. This situation led to the recall of products previously distributed under the registration certificate number 国械注准20153132396. The regulatory framework for this action involves both the NMPA and the Shanghai Municipal Drug Administration, ensuring compliance with national medical device regulations. The company's required action is a voluntary Class III recall, with comprehensive details regarding affected product models, specifications, and batch numbers available in an attached "Medical Device Recall Event Report Form." This measure addresses the documentation discrepancy to uphold regulatory standards for medical device distribution in China.

Company: https://www.globalkeysolutions.net/companies/shanghai-xiaobo-technology-development-co-ltd/bb3830da-8a23-4572-afd6-55ca350a7a8d/