# China NMPA Product Recall - Posterior cervical spine reconstruction fixation plate

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/a1087809-3c36-40d1-ad42-dab7030c012a/
Source feed: China

> China NMPA product recall for Posterior cervical spine reconstruction fixation plate by Synthes GmbH published April 04, 2014. Recall level: . The National Medical Products Administration (NMPA) issued information regarding two voluntary medic

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH of Switzerland recalls posterior cervical spine reconstruction fixation plates
- Company Name: Synthes GmbH
- Publication Date: 2014-04-04
- Product Name: Posterior cervical spine reconstruction fixation plate
- Recall Reason: Inconsistent labeling information in the US market
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) issued information regarding two voluntary medical device recalls, neither of which directly impacted products sold in China. Synthes GmbH, Switzerland, initiated a recall of its Posterior Cervical Spine Reconstruction Fixation Plate due to inconsistent labeling identified in the US market. Its distributor, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., confirmed no products in China were affected, and Chinese provincial regulatory authorities were advised to enhance supervision of similar devices.

Separately, DePuy Orthopaedics, Inc. (USA) recalled specific models of its Rotary Hinge Knee System. The primary issue involved 45 reports between 1999 and 2013 detailing holes in the product's sterile packaging, with a complaint rate of 0.35% from 2010 to 2013. These packaging integrity issues were attributed to repeated shipments over several years. Although the product is indicated for various knee conditions and distributed globally, no affected batch numbers of the Rotary Hinge Knee System were imported or sold in China. Consequently, DePuy Orthopaedics, Inc. reported the situation to the State Food and Drug Administration but stated that no further investigative or corrective actions were required within China, given the lack of local impact. Both instances underscore the NMPA's regulatory oversight in medical device safety.

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