China NMPA Product Recall - Importer

Cook Incorporated has initiated a voluntary Class I recall of certain implant devices, as reported by Cook (China) Medical Trading Co., Ltd. and announced by the National Medical Products Administration (NMPA) on February 7, 2021. This critical action stems from an identified increased possibility of proximal binding site separation within specific models and batches of the affected products. This manufacturing issue poses a significant risk, with the potential for serious adverse events for patients. The recall specifically targets implant devices identified under Registration Certificate Nos. 20153030397 and 20173772039. Comprehensive details regarding the precise models, specifications, and affected batch numbers are accessible through the "E-Event Report Form" and an accompanying PDF attachment. The classification as a Class I recall by the NMPA underscores the severity of the situation, indicating a high probability that the use of, or exposure to, these compromised products could lead to serious adverse health consequences or even death. Consequently, Cook Incorporated is undertaking the necessary actions to remove all affected devices from distribution to safeguard patient safety.