# China NMPA Product Recall - Spinal surgical tools

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/16e761e8-04e8-43d5-86db-d9bd5177f867/
Source feed: China

> China NMPA product recall for Spinal surgical tools by Synthes GmbH published November 07, 2013. Recall level: . The National Medical Products Administration (NMPA) issued a notice on November 7, 2013, concerning 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls spinal surgery tools
- Company Name: Synthes GmbH
- Publication Date: 2013-11-07
- Product Name: Spinal surgical tools
- Recall Reason: Synthes received notification from one of its suppliers that one or more bars in a batch of materials used to produce the affected parts were mixed with the wrong material. The specified material is 420A, and the material mixed in with the bars is X20CrMnNi 12 8 6 (a non-magnetic austenitic steel grade used in generator manufacturing). Using the wrong material will result in the device having lower hardness and corrosion resistance than specified.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) issued a notice on November 7, 2013, concerning a voluntary recall initiated by Synthes GmbH for specific spinal surgical instruments. The recall stemmed from a critical manufacturing issue: the use of incorrect raw materials. It was discovered that a batch of materials, intended to be 420A, was inadvertently contaminated with X20CrMnNi 12 8 6, a non-magnetic austenitic steel. This material deviation would result in the affected instruments having compromised hardness and reduced corrosion resistance, potentially impacting their performance and safety. The recall primarily affects overseas markets, including Spain, Switzerland, the Netherlands, the USA, and Canada. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., representing Synthes in China, formally reported to the State Food and Drug Administration that this recall does not involve the Chinese market. No affected products were imported or sold in China. Consequently, no specific recall actions are required domestically. However, the NMPA mandated that regional food and drug administration departments reinforce their oversight and management of such medical devices to uphold product quality and regulatory compliance.

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