China NMPA Product Recall - Importer

On January 6, 2021, the National Medical Products Administration (NMPA) of China published a notification regarding a voluntary Class I recall initiated by Cook Incorporated. This significant action targets specific models and batches of implant devices, which are identified by Registration Certificate Numbers 20153030397 and 20173772039. The basis for this recall stems from an identified manufacturing issue: an increased possibility of proximal binding site separation within the affected products. Cook (China) Medical Trading Co., Ltd. communicated this critical defect, emphasizing that it could lead to serious adverse events for patients. The classification of this as a Class I recall is critical; it indicates that regulatory authorities, in conjunction with the company, have determined there is a reasonable probability that the use of, or exposure to, these violative products could cause serious adverse health consequences or even death. Consequently, Cook Incorporated is undertaking proactive steps to remove these potentially hazardous devices from the market to mitigate risks and ensure patient safety. Further specific details regarding the impacted product models, specifications, and batch numbers are documented within the accompanying 'E-Event Report Form' and the 'Medical Device Recall Event Report Form' attachment, which are accessible through the NMPA's official channels.