# China NMPA Product Recall - Hollow screw system, bone screw

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/f45c9eaa-1f2c-4278-975c-e3252167ad11
Source feed: China

> China NMPA product recall for Hollow screw system, bone screw by Synthes GmbH published August 23, 2016. Recall level: . The National Medical Products Administration (NMPA) issued a recall notice on August 23, 2016, conce

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls hollow screw systems and bone screws.
- Company Name: Synthes GmbH
- Publication Date: 2016-08-23
- Product Name: Hollow screw system, bone screw
- Recall Reason: The information on the affected product labels does not match the indications registered in Canada, and no adverse effects on patients or systemic safety issues have been indicated.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) issued a recall notice on August 23, 2016, concerning medical devices from Synthes GmbH, distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. This voluntary recall, reported on August 15, 2016, involved Hollow Screw Systems and Bone Screws. The main violation was that the product label information did not match the indications registered in Canada. This issue was classified as a safety notice, with no reported adverse patient effects or systemic safety concerns. Under the NMPA's regulatory framework, Synthes GmbH initiated a voluntary recall to correct product labels in the affected markets of the United States and Canada. Crucially, the document confirmed that none of the affected products were imported into or sold within China, meaning no specific corrective actions were required domestically. However, the NMPA mandated that regional food and drug administrations strengthen their supervision and management of similar products.

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