China NMPA Product Recall - APS Metal Plate & Screw System

On September 1, 2020, Apex (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its APS Metal Plate & Screw System. This action, overseen by the National Medical Products Administration (NMPA) and announced via the Shanghai Municipal Drug Administration, stemmed from a national medical device spot check. The investigation revealed that the product's fracture torsion angle did not meet the company's self-defined technical specifications, indicating a potential issue with the device's structural integrity and performance. While specific inspection dates were not provided, the identification of this non-conformance during a routine spot check prompted the recall. The required action for Apex (Shanghai) Trading Co., Ltd., also referred to as Aps (Shanghai) Trading Co., Ltd., is to retrieve all affected units of the APS Metal Plate & Screw System. Details regarding the involved product models, specifications, and batches are available in the attached Medical Device Recall Event Report Form. This recall emphasizes the regulatory framework's role in ensuring manufacturers comply with established product quality and safety standards for medical devices.