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

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/9fe03c34-67a3-4093-8571-28da48cd81b8/
Source feed: China

> China NMPA product recall for Trauma surgical instrument kit, orthopedic drill bits by Synthes GmbH published February 20, 2017. Recall level: . The National Medical Products Administration (NMPA) reported a voluntary recall initiated by Synthes

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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: 2017-02-20
- 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: The National Medical Products Administration (NMPA) reported a voluntary recall initiated by Synthes GmbH, a medical device manufacturer, concerning trauma surgical instrument kits and orthopedic drills. Distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the affected products included specific batches of trauma surgical instrument kits (registration number: 国械备20150914) and orthopedic drills (registration number: 国械彳 20140324).

The primary defect identified was an asymmetrical hexagonal construction in the flexible shaft (352.040) of the trauma kits and the movable extension rod (352.044) of the orthopedic drills. This manufacturing flaw resulted in uneven hexagonal side lengths and a misaligned center, potentially causing a mismatch with the reamer heads these components are intended to house. Such a malfunction could compromise the effectiveness of surgical procedures.

Synthes GmbH commenced the recall as a precautionary measure. Crucially, the recalled products were not sold in China. Therefore, under the NMPA's regulatory guidance, no direct corrective actions are mandated for products within the Chinese market. However, the NMPA requested that provincial regulatory authorities strengthen their oversight of similar medical devices, emphasizing continuous vigilance in medical device safety.

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