# China NMPA Product Recall - Small electric systems

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/7afdf99d-8b59-48b0-91fd-781ed9809c3e
Source feed: China

> China NMPA product recall for Small electric systems by Synthes GmbH published December 22, 2014. Recall level: Level III. On December 22, 2014, the National Medical Products Administration (NMPA) and the Shanghai Municipal

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls small electric systems.
- Company Name: Synthes GmbH
- Publication Date: 2014-12-22
- Product Name: Small electric systems
- Recall Level: Level III
- Recall Reason: The manufacturer has identified potential malfunction modes in this small power-operated system (SED), such as the instrument failing to function, operating only in reverse mode, or failing to reverse when the instrument is activated/not as intended. If the instrument fails to function during operating room testing, the user is likely to discontinue use of the affected component and purchase a power tool as a replacement, potentially leading to surgical delays. Due to operator negligence, the handle may be further inserted into the surgical site. Unintended activation of the handle or incorrect mode/direction may result in bone/soft tissue injury, peripheral nerve injury, and/or vascular injury, which may require surgical/medical intervention.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: On December 22, 2014, the National Medical Products Administration (NMPA) and the Shanghai Municipal Food and Drug Administration announced a Class III voluntary recall initiated by Synthes GmbH, with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. acting as the responsible unit in China. The recall pertains to the Small Powered System (SED), model 05.001.175.
The primary issue identified by the manufacturer is that the SED may exhibit critical fault modes, including complete device failure, operation exclusively in reverse, or unintended activation of the reverse mode. These malfunctions pose significant risks during surgical procedures. If the device fails during operation, it could lead to surgical delays as users seek replacements. More critically, unintended activation or incorrect operational modes could result in serious patient harm, such as bone/soft tissue injury, peripheral nerve injury, or vascular injury, potentially necessitating additional surgical or medical intervention.
Although the product was imported into China, it was not sold within the country. The recall was enacted to mitigate potential risks associated with the faulty device. This action reflects the regulatory framework's commitment to patient safety, requiring immediate action when medical device defects are identified, even if the product has not entered the consumer market.

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