China NMPA Product Recall - Miniature oscillating saw

On August 30, 2016, the National Medical Products Administration (NMPA) publicized a voluntary Class II recall initiated by Medtronic (Shanghai) Management Co., Ltd. The recall, reported by Medtronic on June 20, 2016, addresses a critical issue identified in their Miniature Oscillating Saw (models ES310, ES300).

Medtronic's internal testing revealed a potential problem with the sealing of the saw's housing, which could allow liquid to seep into the device. Further assessments indicated that if liquid ingress occurs, the gravity displacement sterilization cycle detailed in the Medtronic Integrated Surgical Power System (IPC®) instruction manual might be insufficient to ensure the sterility of internal components. This poses a significant risk as the product, intended for cutting tissue and bone during surgery, must maintain sterility.

The affected products include specific serial numbers in China: P06120725, P06122026, P06237044, and P06238411, with four units sold in China as part of a global recall. To mitigate this potential patient safety risk, Medtronic has implemented corrective actions. The company issued notification letters to all affected distributors and hospitals, instructing them to return all identified products to Medtronic. This proactive measure aims to prevent any non-sterile devices from being used in surgical procedures.