# China NMPA Product Recall - Spinal Surgical Implants - Screws for Anterior Cervical Locking Plate

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/ba4501e2-ccef-4c4a-b899-76aeb7c6112f/
Source feed: China

> China NMPA product recall for Spinal Surgical Implants - Screws for Anterior Cervical Locking Plate by Synthes GmbH published February 25, 2016. Recall level: . Synthes GmbH, a subsidiary of Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a vo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls screws for spinal surgery implants – anterior cervical locking plates.
- Company Name: Synthes GmbH
- Publication Date: 2016-02-25
- Product Name: Spinal Surgical Implants - Screws for Anterior Cervical Locking Plate
- Recall Reason: The manufacturer discovered that a batch of screws, model number 450.016, was using labels and packaging from other screws. The affected products were not sold in China, and there are no related complaints in China.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Synthes GmbH, a subsidiary of Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall for its spinal surgery implants—screws for anterior cervical locking plates (Model 450.016, NMPA Registration No. 20153462717). The recall was reported on January 19, 2016, and published by the National Medical Products Administration (NMPA) on February 25, 2016. The core issue was a labeling and packaging error where a specific batch of screws was incorrectly packaged with labels intended for other screw types. Critically, the company confirmed that the affected products were not distributed or sold within China, and no related complaints were reported in the country. Under the regulatory oversight of the NMPA, since the products were not in the Chinese market, no direct corrective actions were mandated for the company in China. However, the NMPA requested provincial food and drug administrations to enhance their management and oversight of similar medical devices.

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