# China NMPA Product Recall - Bioabsorbable bone material made of poly-L-lactide

Source: https://www.globalkeysolutions.net/records/china_product_recall/xinqiaotong-technology-dalian-co-ltd/040cf9a1-8301-4b6c-895b-5170e5b53649/
Source feed: China

> China NMPA product recall for Bioabsorbable bone material made of poly-L-lactide by Xinqiaotong Technology (Dalian) Co., Ltd. published July 27, 2020. Recall level: Level 3 Recall. Xinqiaotong Technology (Dalian) Co., Ltd. initiated a voluntary Class III recall of its Poly(L-lacti

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Xinqiaotong Technology (Dalian) Co., Ltd. has initiated a voluntary recall of its poly-L-lactide bioabsorbable bone-healing materials.
- Company Name: Xinqiaotong Technology (Dalian) Co., Ltd.
- Publication Date: 2020-07-27
- Product Name: Bioabsorbable bone material made of poly-L-lactide
- Recall Level: Level 3 Recall
- Recall Reason: The product packaging label is not standardized, and the product name in the instruction manual does not match the actual product name on the outer packaging.
- Discovering Company: Xinqiaotong Technology (Dalian) Co., Ltd.
- Manufacturing Company: Xinqiaotong Technology (Dalian) Co., Ltd.
- Summary: Xinqiaotong Technology (Dalian) Co., Ltd. initiated a voluntary Class III recall of its Poly(L-lactide) Bioabsorbable Bone-Setting Material (Registration or Filing Number: 20143136139) as reported by the National Medical Products Administration (NMPA) and the Liaoning Provincial Drug Administration on July 27, 2020. The primary issues leading to this action involved non-standard labeling on the product's outer packaging and inconsistencies between the product name listed in the instruction manual and the actual product name on the exterior packaging. This recall falls under the regulatory oversight of China's National Medical Products Administration. The company's required action is to voluntarily remove the affected product from the market due to these labeling and documentation discrepancies. Further details regarding specific product models and specifications are available in the "Medical Device Recall Event Report Form" referenced by the NMPA.

Company: https://www.globalkeysolutions.net/companies/xinqiaotong-technology-dalian-co-ltd/79ac9485-2b92-4c97-a3c1-1e433d4128b2/