# China NMPA Product Recall - Craniofacial internal fixation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/5c9b128b-9452-4a0d-b07d-c840ba6262d8/
Source feed: China

> China NMPA product recall for Craniofacial internal fixation system by Synthes GmbH published April 13, 2016. Recall level: . The National Medical Products Administration (NMPA) issued a notice regarding a voluntary recall of 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls craniofacial surgical internal fixation systems
- Company Name: Synthes GmbH
- Publication Date: 2016-04-13
- Product Name: Craniofacial internal fixation system
- Recall Reason: The affected product packaging contains 6mm long screws, but the packaging label may have incorrectly labeled them as 8mm. If the screw is measured before implantation, the user will find that it is 2mm shorter than the length indicated on the packaging label, and replacing the screw may cause surgical delays. If this problem is not detected before use, a screw that is 2mm shorter than the assumed length may pose a risk to the patient of not achieving bicortical fixation, especially in the case of implanting multiple incorrectly labeled (shorter) screws, which may also lead to screw loosening. In addition, loose screws may cause soft tissue irritation to the patient, and the screw head may irritate surrounding tissues.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) issued a notice regarding a voluntary recall of the Craniofacial Surgery Internal Fixation System manufactured by Synthes GmbH and distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall, reported on March 24, 2016, stemmed from significant packaging labeling errors. Specifically, certain product packaging contained a 6mm long screw but was incorrectly labeled as 8mm. This discrepancy presented several potential issues: if identified before implantation, it could lead to surgical delays while replacement screws are obtained. More critically, if the incorrect, shorter screws are implanted unknowingly, there is a risk of failing to achieve bicortical fixation, potentially resulting in screw loosening. Loose screws could further cause patient discomfort and soft tissue irritation. According to the report, no affected products were imported into or sold within China. Consequently, no direct corrective actions were required from Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. in the Chinese market. However, the NMPA requested provincial and municipal food and drug administrations to strengthen their supervision and management of similar medical devices to mitigate future risks. The recall primarily impacted regions such as Japan and Belgium.

Company: https://www.globalkeysolutions.net/companies/synthes-gmbh/77a06946-ba7a-4bf2-916a-600eabfb0ce7/