# China NMPA Product Recall - Double fixing screw system

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc-orthopedic-division/51a6a7a2-73ff-4500-bcee-dea7af9d6e24/
Source feed: China

> China NMPA product recall for Double fixing screw system by Smith & Nephew, Inc. Orthopedic Division published January 15, 2020. Recall level: Level 2 Recall. Smith & Nephew Inc. initiated a voluntary Class II recall on January 15, 2020, for its Dual Fixation

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Inc. voluntarily recalls dual-fixing screw systems.
- Company Name: Smith & Nephew, Inc. Orthopedic Division
- Publication Date: 2020-01-15
- Product Name: Double fixing screw system
- Recall Level: Level 2 Recall
- Recall Reason: The protective sleeve of certain models or batches of products may detach inside the packaging bag, causing the tip to puncture the aseptic packaging and affecting product quality.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew, Inc. Orthopedic Division
- Summary: Smith & Nephew Inc. initiated a voluntary Class II recall on January 15, 2020, for its Dual Fixation Screw Systems, impacting specific models and batches. This action was reported by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. to the National Medical Products Administration (NMPA). The recall stems from a critical product safety concern where the protective sleeve designed for the device may detach within the sterile packaging. This detachment poses a significant risk, as it can cause the device's tip to puncture the sterile barrier, compromising the sterility of the product before use. Such a breach in sterility directly impacts patient safety, making the product potentially unsafe for its intended medical application. The NMPA oversees this regulatory action, ensuring that affected products are removed from circulation to mitigate potential health risks. Further comprehensive details regarding the specific models and batch numbers subject to this recall are officially documented in the accompanying Medical Device Recall Event Report Form, providing essential information for affected parties.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-inc-orthopedic-division/82243c50-18e1-44ef-893f-7042c1105847/