# China NMPA Product Recall - Thoracolumbar fixation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/24ae9c27-bbaa-432b-af88-9deb7c1dabdf
Source feed: China

> China NMPA product recall for Thoracolumbar fixation system by Synthes GmbH published April 19, 2013. Recall level: . The National Medical Products Administration (NMPA) published an announcement on April 19, 2013, reg

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls thoracolumbar fixation systems.
- Company Name: Synthes GmbH
- Publication Date: 2013-04-19
- Product Name: Thoracolumbar fixation system
- Recall Reason: Incorrect laser etching; a screw with a diameter of 7.0 mm was etched to 4.2 mm.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) published an announcement on April 19, 2013, regarding a voluntary recall initiated by Synthes GmbH, a medical device manufacturer. This recall pertains to certain batches of its Thoracolumbar Spine Fixation System, registered under CFDA (Imported) No. 20123460787 (Revised). The primary issue identified was incorrect laser etching, where a 7.0mm screw diameter was erroneously marked as 4.2mm on product number 499.142, batch number 2390589. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the responsible unit in China, reported the incident. However, the recall does not impact China, as the affected product batches were not imported into the country, despite being registered for sale. The manufacturer stated that the recall involved regions such as Austria, Switzerland, Germany, and the Netherlands. Consequently, Johnson & Johnson Shanghai will report the situation to the State Food and Drug Administration but will not implement further recall measures within China. The NMPA requested provincial, autonomous region, and municipal food and drug administrations to enhance the management of such products.

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