# China NMPA Product Recall - Bone fusion implants - hollow bone screws/strapping screws/steel nail fixation systems

Source: https://www.globalkeysolutions.net/records/china_product_recall/general-medical-equipment-shanghai-co-ltd/bad40cd8-d7ce-4db3-add7-559cbe642b2f/
Source feed: China

> China NMPA product recall for Bone fusion implants - hollow bone screws/strapping screws/steel nail fixation systems by General Medical Equipment (Shanghai) Co., Ltd. published December 05, 2018. Recall level: . General Medical Devices (Shanghai) Co., Ltd. initiated a voluntary recall of its bone fitting implan

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its bone graft implants – hollow bone screws/screws/steel nail fixation systems.
- Company Name: General Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2018-12-05
- Product Name: Bone fusion implants - hollow bone screws/strapping screws/steel nail fixation systems
- Recall Reason: A malfunction in the supplier's sealing equipment resulted in inadequate sterilization of certain models/batch numbers of bone graft implants—cannon bone screws/suture fixation systems/steel nail fixation systems—potentially affecting the product's sterility.
- Discovering Company: General Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: General Medical Equipment (Shanghai) Co., Ltd.
- Summary: General Medical Devices (Shanghai) Co., Ltd. initiated a voluntary recall of its bone fitting implants, specifically hollow bone screws, stabilized screws, and steel nail fixation systems, as reported on December 5, 2018. This action, classified as a medical device recall under the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration (recall number 2018-279), was prompted by a critical issue affecting product sterility. The primary violation stemmed from a malfunction in a supplier's sealing equipment, leading to inappropriate sterilization levels for certain models and batch numbers of the implants. This deficiency potentially compromised the sterility performance of these medical devices. Consequently, General Medical Devices (Shanghai) Co., Ltd. is actively recalling the affected products, which include bone fusion implants – hollow bone screw/suture fixation systems (Registration Certificate No.: CFDA Import/Export No. 20143463241). Detailed information about the specific affected product models, specifications, and batches is available in the accompanying "Medical Device Recall Event Report Form," ensuring transparency and proper management of the recall process. This measure underscores the company's commitment to patient safety and adherence to regulatory standards.

Company: https://www.globalkeysolutions.net/companies/general-medical-equipment-shanghai-co-ltd/e78bec1e-b5e6-44db-9c62-8b77dec44ed4/