China NMPA Product Recall - Metal locking plate internal fixation system

Guangdong Steibo Medical Technology Co., Ltd. initiated a voluntary recall of its manufactured Metal Locking Plate Internal Fixation System. This regulatory action was reported on September 22, 2020, operating under the regulatory framework of the National Medical Products Administration (NMPA), with the announcement disseminated via the Guangdong Provincial Drug Administration Website. The recall is categorized as Level III, indicating that the use of or exposure to the affected product is not expected to cause serious adverse health consequences. While the specific issues or violations prompting this recall are not detailed in the public notice, the company has confirmed that comprehensive information regarding the precise models, specifications, and batch numbers of the impacted devices is contained within a "Medical Device Recall Event Report Form." This detailed document, referenced as "Foshan Steibo - Locking Plate Recall Incident Report Form.pdf," provides all necessary product-specific data. The required action involves the company's diligent execution of this Level III voluntary recall, ensuring proper management and removal of the identified medical devices in compliance with NMPA's stringent standards for medical product safety and market regulation.