# China NMPA Product Recall - Intramedullary nail system

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/9bb977ff-de44-4bef-a362-f98916d4fcee/
Source feed: China

> China NMPA product recall for Intramedullary nail system by Synthes GmbH published December 10, 2015. Recall level: . Synthes GmbH initiated a voluntary recall of a specific batch of its intramedullary nail system, a m

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls intramedullary nail system
- Company Name: Synthes GmbH
- Publication Date: 2015-12-10
- Product Name: Intramedullary nail system
- Recall Reason: The manufacturer's evaluation revealed that one batch of hip screws could not pass through the opening of the proximal femoral intramedullary nail due to excessively large thread outer and inner diameters. If this occurs during surgery, the inability to insert the hip screw into the designated hole of the proximal femoral intramedullary nail may lead to surgical delays. It is recommended to find a hip screw of the specified size in the surgical kit for replacement. If the hip screw cannot be inserted during the initial insertion of the proximal femoral intramedullary nail and no replacement can be found, it will result in surgical delays, or even termination of the procedure, requiring a second surgery after confirming that a suitable hip screw or alternative system is available.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Synthes GmbH initiated a voluntary recall of a specific batch of its intramedullary nail system, a medical device for internal fixation of long bone fractures, as documented in a National Medical Products Administration (NMPA) notice published on December 10, 2015. The recall report, submitted by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on October 26, 2015, detailed the primary issue: excessively large thread outer and inner diameters on certain hip screws. This manufacturing flaw could prevent the hip screws from properly passing through the opening of the proximal femoral intramedullary nail during surgical procedures. Such a malfunction would lead to significant surgical delays or potentially require the termination of the operation, necessitating a subsequent reoperation with suitable components. Critically, Johnson & Johnson confirmed that the affected product batch was neither imported nor sold within China. Therefore, under the NMPA's regulatory framework, while the recall was reported, no further corrective actions, investigation, or implementation plans were deemed necessary for the Chinese market. Regional food and drug administrations were, however, instructed to strengthen supervision over similar medical products. The recall affected other regions, including Austria, Italy, Kenya, and Taiwan.

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