China NMPA Product Recall - Universal spinal internal fixation device - universal pedicle screw

Beijing Libel Bioengineering Research Institute Co., Ltd. initiated a voluntary Class III recall of its Universal Spinal Internal Fixation Device with Universal Pedicle Screw (National Medical Device Registration Certificate: 20163460826). This action, reported to the National Medical Products Administration (NMPA) on May 22, 2017, and publicly released on May 28, 2019, followed customer complaints concerning the dislodgement of ball-head screws during surgical implantation. Investigations by the company identified several potential contributing factors. These included variations in customer operating environments, operators not adhering to recommended torque wrench usage, and repeated manipulation of implants. Furthermore, a process change implemented on May 7, 2016, which shifted the gasket finishing from polishing to centrifugal grinding, was implicated. This change led to the elimination of one dimensional inspection and reduced frequency for others, despite initial Design of Experiments (DOE) results. The company also noted that equipment evaluations (EIQ/EOQ) conducted under 2012 quality system requirements were not re-confirmed per 2016 standards. Additionally, a retrospective review found that three critical manufacturing dimensions were not properly identified as Critical To Quality (CTQ). Despite not pinpointing a direct cause, Beijing Libel proactively recalled approximately 58,552 affected units distributed in China and Thailand to mitigate potential risks associated with unused products. The required actions involve notifying distributors and managing the return and processing of recalled devices according to internal protocols.