# China NMPA Product Recall - Intramedullary nail system (trade name: TRIGEN) and combined compression interlocking intramedullary nail system (trade name: TriGen InterTAN).

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc-orthopedic-division/b4d40bf5-c408-4389-af77-a86d4bb15d49/
Source feed: China

> China NMPA product recall for Intramedullary nail system (trade name: TRIGEN) and combined compression interlocking intramedullary nail system (trade name: TriGen InterTAN). by Smith & Nephew, Inc. Orthopedic Division published April 28, 2014. Recall level: . Smith & Nephew Inc. initiated a voluntary recall for specific Orthopaedic Intramedullary Nail System

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Inc. of Orthopaedic is recalling its intramedullary nail system and combined compression interlocking intramedullary nail system.
- Company Name: Smith & Nephew, Inc. Orthopedic Division
- Publication Date: 2014-04-28
- Product Name: Intramedullary nail system (trade name: TRIGEN) and combined compression interlocking intramedullary nail system (trade name: TriGen InterTAN).
- Recall Reason: Due to a manufacturing defect in the TRIGEN™ INTERTANT™ NAILS, the stabilizing screw was driven too deeply into the master screw. During surgery, when drilling into the proximal femoral screw hole to insert the traction and compression screw, the drill bit may rub against the stabilizing screw, posing a risk of drill bit fatigue fracture.
- 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 recall for specific Orthopaedic Intramedullary Nail Systems (TRIGEN) and Combined Compression Interlocking Intramedullary Nail Systems (TriGen InterTAN). The recall, publicly announced on April 28, 2014, by China's National Medical Products Administration (NMPA) and originating from a report received on April 18, 2014, addresses a significant manufacturing error. This error resulted in the stabilizing screw being screwed too deeply into the main nail. The primary concern is that during surgical implantation, the drill bit could rub against this deeply set screw, potentially causing drill bit fatigue fracture. It was clarified that for products already successfully implanted where this friction did not occur, their function and lifespan remain unaffected, and no clinical follow-up is necessary. The regulatory framework underpinning this action involved the NMPA requesting provincial food and drug administrations to strengthen supervision over these products, which had been distributed internationally including in Europe, North America, Asia, and Australia. Required actions by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. included issuing recall notices to distributors and hospitals, diligently collecting all recall-related documentation, and facilitating the retrieval of affected products. These products were to be consolidated at the Shanghai warehouse before being returned to the U.S. manufacturing plant for processing. The company also committed to providing distributors with either an equivalent number of replacement products or a full refund for all returned items.

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