# China NMPA Product Recall - Bone screws

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/b8607b07-577f-4485-978c-e50b8b0e22b3/
Source feed: China

> China NMPA product recall for Bone screws by Synthes GmbH published September 18, 2014. Recall level: . The National Medical Products Administration (NMPA) published a recall notice on September 18, 2014,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH of Switzerland recalls bone screws
- Company Name: Synthes GmbH
- Publication Date: 2014-09-18
- Product Name: Bone screws
- Recall Reason: Due to a manufacturing error, 3.5mm cortical bone screws (self-tapping, 30mm long, stainless steel) with product number 204.828 were packaged with unpolished threads and deformed heads, and were marked as 3.5mm cortical bone screws (28mm long, stainless steel) with product number 204.028.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) published a recall notice on September 18, 2014, concerning bone screws manufactured by Synthes GmbH. This voluntary recall was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on September 15, 2014, following the discovery of manufacturing errors. Specifically, 3.5mm cortical bone screws (product number 204.828) were found to have unpolished threads and deformed tips, while some packages for product 204.828 contained incorrectly labeled 3.5mm cortical bone screws (28mm long) with the product number 204.028. These issues presented a potential risk related to product quality and labeling accuracy. The regulatory framework for this recall falls under the NMPA. Although the affected bone screws are utilized for internal fixation of fractures and were distributed to numerous international markets, including countries in Europe, the Middle East, Asia, and Australia, the reporting company confirmed that none of the affected batches were imported into or sold within China. Consequently, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. stated that no additional company-level actions, such as further investigations or implementation plans, would be initiated beyond their initial report to the regulatory authorities. However, the NMPA mandated that food and drug administrations across all Chinese provinces strengthen their supervision of such medical devices to ensure public safety.

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