# China NMPA Product Recall - Locking screws and bone screws

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/f77319bf-926c-4923-8945-08a81d5a2bd1/
Source feed: China

> China NMPA product recall for Locking screws and bone screws by Synthes GmbH published March 11, 2016. Recall level: . Synthes GmbH, a subsidiary of Johnson & Johnson, initiated a voluntary recall of its locking bone sc

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls locking bone screws and bone screws.
- Company Name: Synthes GmbH
- Publication Date: 2016-03-11
- Product Name: Locking screws and bone screws
- Recall Reason: The manufacturer discovered that the two affected batches of products may have been labeled with labels from other products, affecting the product quality.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Synthes GmbH, a subsidiary of Johnson & Johnson, initiated a voluntary recall of its locking bone screws and bone screws due to an incorrect labeling issue. The company discovered that two specific batches of these medical devices may have been mislabeled with information pertaining to other products. This recall was formally reported to China's National Medical Products Administration (NMPA) on February 29, 2016, and subsequently published on March 11, 2016, under NMPA index JGXX-2016-10035. Significantly, Synthes GmbH confirmed that none of the affected products were imported or sold within mainland China. Consequently, no direct corrective actions were required from the company within the Chinese market. The recall's international scope included regions such as Australia, Hong Kong, New Zealand, France, Germany, the United Kingdom, Italy, Saudi Arabia, Sweden, and Peru. In response, the NMPA, operating under its regulatory framework, instructed provincial and autonomous region drug administrations to enhance their supervision and management of similar medical products to safeguard public health.

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