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

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.