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

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/73ee4e5d-e33b-42e5-baf6-00909052fd5a/
Source feed: China

> China NMPA product recall for Trauma surgical instrument kit, orthopedic drill bits by Synthes GmbH published January 12, 2017. Recall level: . On January 12, 2017, the National Medical Products Administration (NMPA) issued a recall notice rega

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls trauma surgical instrument kits and orthopedic drills.
- Company Name: Synthes GmbH
- Publication Date: 2017-01-12
- Product Name: Trauma surgical instrument kit, orthopedic drill bits
- 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: On January 12, 2017, the National Medical Products Administration (NMPA) issued a recall notice regarding medical devices manufactured by Synthes GmbH and distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The affected products include trauma surgical instrument kits (registration number: 国械备20150914) and orthopedic drills (registration number: 国械备20140324).

The primary concern identified was a manufacturing defect involving asymmetrical hexagonal couplers. Specifically, the flexible shaft (352.040) in the surgical kits and the movable extension rod (352.044) in the orthopedic drills presented inconsistent hexagonal side lengths and off-center placement. This defect could lead to a mismatch between the flexible shaft and the head of the nested reamer during surgical use.

Synthes GmbH has initiated a voluntary recall for these products, confirming that none of the recalled items were sold in China. The NMPA, operating within its regulatory framework, has instructed the Food and Drug Administration offices in all provinces, autonomous regions, and municipalities to enhance their supervision and management of similar products to ensure patient safety and compliance with medical device standards.

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