# China NMPA Product Recall - Modular electric drill system

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/b2be1b03-d0c5-4778-a432-660d83aa082f
Source feed: China

> China NMPA product recall for Modular electric drill system by Synthes GmbH published April 21, 2016. Recall level: . Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., working with manufacturer Synthes GmbH, init

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls modular electric drill systems.
- Company Name: Synthes GmbH
- Publication Date: 2016-04-21
- Product Name: Modular electric drill system
- Recall Reason: The manufacturer discovered that the affected product contains a manufacturing defective component that could cause premature product failure. If failure occurs, the charger firmware will detect the fault and block battery charging. According to the user manual, the blue LED on the front of the charger will flash at this time, indicating that the device needs to be sent to a designated repair shop. Upon failure, the device firmware will put the affected product into a "safe mode," which may delay the procedure.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., working with manufacturer Synthes GmbH, initiated a voluntary recall of its Modular Electric Drill Systems (Model 05.001.204). This action was reported to the National Medical Products Administration (NMPA), previously CFDA, on March 7, 2016, with publication on April 21, 2016. The recall stemmed from the discovery of a defective component within the device, which could lead to premature product failure. Such a malfunction would cause the charger firmware to block battery charging and force the device into a "safe mode," potentially causing critical delays during surgical procedures, particularly in trauma orthopedics and joint surgery. An indication of this fault is a flashing blue LED, signaling the need for repair. Although 14 units of the affected product were imported into China, none had been sold. Johnson & Johnson implemented a corrective action plan involving on-site repairs for any confirmed faulty products to address the issue and ensure patient safety and surgical continuity, adhering to regulatory expectations for product quality.

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