China NMPA Product Recall - Composite calcium phosphate bone implant material

Shanghai Ruixing Medical Equipment Co., Ltd. initiated a voluntary Class III recall of its composite calcium phosphate bone implant material, as announced by the National Medical Products Administration (NMPA) on September 30, 2021. The decision to recall was prompted by identified deficiencies concerning product documentation and labeling. Specifically, the company found that the affected medical devices had missing instructions and lacked essential labels on their smallest packaging units. The recall pertains to products registered under Certificate No. "国械注准20153131017". Although no specific inspection dates were provided, the recall information was disseminated through the Shanghai Municipal Drug Administration website, highlighting regulatory oversight from the NMPA, which is responsible for medical device safety and quality standards. The required action involves the company actively recalling the non-compliant product batches, with comprehensive details regarding models, specifications, and batch numbers made available in the "Medical Device Recall Event Report Form". This proactive measure demonstrates Shanghai Ruixing Medical Equipment Co., Ltd.'s commitment to rectifying product discrepancies and adhering to regulatory requirements for medical device information and packaging.