# China NMPA Product Recall - Locking bone screws

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/8918f7b8-a632-4596-a4a6-acf6076354fb/
Source feed: China

> China NMPA product recall for Locking bone screws by Synthes GmbH published July 17, 2013. Recall level: . The National Medical Products Administration (NMPA) published a report on July 17, 2013, detailing a

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls locking bone screws.
- Company Name: Synthes GmbH
- Publication Date: 2013-07-17
- Product Name: Locking bone screws
- Recall Reason: Syndis received three complaints regarding incorrect product packaging. Product 413.020592745382 was correctly packaged in the first layer after the first sterilization, but the outer packaging, including the label, was incorrectly packaged during the second sterilization. This resulted in a mismatch between the inner and outer packaging.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) published a report on July 17, 2013, detailing a voluntary recall initiated by Synthes GmbH for specific locking bone screws (SFDA(I)20103462425(Revised)). This action, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. in June 2013, stemmed from three complaints regarding incorrect product packaging. The core issue involved a mismatch between the inner and outer packaging for product numbers 413.010S (batch 2747402) and 413.020S (batch 2745382) following a secondary sterilization process. The affected regions include Austria, France, the United Kingdom, Italy, the Netherlands, and Japan. Importantly, the recall was an overseas event and did not involve China; despite the product being registered for import, no units were actually imported or sold domestically. Therefore, the Chinese responsible unit reported the situation to the State Food and Drug Administration (SFDA) but did not undertake further recall measures within China. The NMPA advised provincial food and drug administrations to enhance their supervision of similar medical devices.

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