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

Source: https://www.globalkeysolutions.net/records/china_product_recall/beijing-libel-biotechnology-research-institute-co-ltd/3f9ad326-9aeb-4be6-a839-c71b688ad6d5/
Source feed: China

> China NMPA product recall for Universal spinal internal fixation device - universal pedicle screw by Beijing Libel Biotechnology Research Institute Co., Ltd. published May 28, 2019. Recall level: Level 3 Recall. Beijing Libel Bioengineering Research Institute Co., Ltd. initiated a voluntary Class III recall of 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beijing Libel Bioengineering Research Institute Co., Ltd. is voluntarily recalling the universal spinal internal fixation device, the pedicle screw.
- Company Name: Beijing Libel Biotechnology Research Institute Co., Ltd.
- Publication Date: 2019-05-28
- Product Name: Universal spinal internal fixation device - universal pedicle screw
- Recall Level: Level 3 Recall
- Recall Reason: Recently, a small number of customer complaints have arisen regarding the dislodgement of ball-head screws during implantation of the Universal Spinal Internal Fixation Device - Long Arm Universal Pedicle Screw. An internal investigation has not identified a direct cause for this failure, but the following potential contributing factors have been identified: 1. The customer's actual usage environment; the operator did not use the torque wrench recommended by our company (potentially causing excessive screw stress), and unnecessary repetitive operations occurred during product implantation, with screws being removed and then re-implanted under certain circumstances; 2. It may be related to a process change implemented on May 7, 2016. This change altered the process of the gaskets in the Universal Spinal Internal Fixation Device - Long Arm Universal Pedicle Screw assembly from polishing to centrifugal grinding. After a Design of Experiment (DOE) was conducted, one dimension inspection of the gaskets was eliminated based on the results, and the inspection frequency of other dimensions was reduced. However, the investigation revealed that this equipment was introduced in 2012 and underwent equipment evaluation according to the original quality system requirements, but the EIQ and EOQ verifications were not re-performed according to the 2016 quality system requirements. Furthermore, based on a retrospective study during the investigation, it was found that three process control dimensions of the product were not identified as CTQ dimensions. Following our risk analysis, although the direct cause of the failure has not been confirmed, to avoid or reduce the potential risks of unused products, we have initiated a proactive recall of the marketed but unused implants.
- Discovering Company: Beijing Libel Biotechnology Research Institute Co., Ltd.
- Manufacturing Company: Beijing Libel Biotechnology Research Institute Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/beijing-libel-biotechnology-research-institute-co-ltd/189f27d9-c8b7-4803-ba10-3ace119e5444/