China NMPA Product Recall - USS II Polyaxial Pedicle Screw Fixation System

On December 6, 2019, the National Medical Products Administration (NMPA) announced a significant Class I voluntary recall initiated by medical device manufacturer, Synthes GmbH. This action, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., addresses critical quality issues with the USS II Polyaxial Multiaxial Pedicle Screw Fixation System (NMPA Product Number: 20173462011). The primary concerns identified by Synthes GmbH involve the potential for intraoperative noise and, more critically, the cracking of the locking ring component within the device. These defects prompted the comprehensive recall to mitigate potential risks to patient safety during surgical procedures. The Class I recall designation is the most serious type of recall, indicating that use of the affected product could reasonably be expected to cause serious adverse health consequences or even death. Consequently, Synthes GmbH is required to retrieve all affected units from the market. The regulatory framework for this action is governed by the NMPA, which oversees medical device safety and ensures manufacturers comply with established standards. Full details concerning specific affected product models, specifications, and batch numbers are provided in the "Medical Device Recall Event Report Form" and supplementary documents, facilitating the effective removal of the compromised devices from circulation to protect public health.