# China NMPA Product Recall - Trauma surgical instrument kit and orthopedic drill

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/4dd0971d-d065-4579-a3b8-098324bf7e53/
Source feed: China

> China NMPA product recall for Trauma surgical instrument kit and orthopedic drill by Synthes GmbH published January 11, 2017. Recall level: . The National Medical Products Administration (NMPA) published a recall notice on January 11, 2017, c

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls trauma surgical instrument kits and orthopedic drills.
- Company Name: Synthes GmbH
- Publication Date: 2017-01-11
- Product Name: Trauma surgical instrument kit and orthopedic drill
- Recall Reason: The flexible shaft (352.040) and movable extension rod (352.044) of the trauma surgical instrument kit in the affected batch may have been made with an asymmetrical hexagonal coupler, resulting in different lengths of each side of the hexagon and the center of the hexagon not being located on the center line. This may cause the flexible shaft to be mismatched with the tip of the reamer it is nested in.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) published a recall notice on January 11, 2017, concerning trauma surgical instrument kits and orthopedic drills manufactured by Synthes GmbH and distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall, initially reported by Johnson & Johnson on January 21, 2016, addresses a manufacturing defect in specific components. The flexible shaft (model 352.040) of the trauma surgical instrument kit and the movable extension rod (model 352.044) of the orthopedic drill were found to have asymmetrical hexagonal couplers. This defect results in uneven side lengths of the hexagon, which could prevent the flexible shaft from correctly matching with the head of its nested reamer, potentially affecting the functionality of these Class I medical devices.

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