# China NMPA Product Recall - Craniofacial surgical instruments (trade name: SYNTHES) and craniofacial bone plates (trade name: Synthes)

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/6b7b35b3-2f3a-405c-9e39-ec0aeecb2991/
Source feed: China

> China NMPA product recall for Craniofacial surgical instruments (trade name: SYNTHES) and craniofacial bone plates (trade name: Synthes) by Synthes GmbH published December 10, 2015. Recall level: . Synthes GmbH, distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a vol

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH is recalling craniofacial surgical instruments (trade name: SYNTHES) and craniofacial bone plates (trade name: Synthes).
- Company Name: Synthes GmbH
- Publication Date: 2015-12-10
- Product Name: Craniofacial surgical instruments (trade name: SYNTHES) and craniofacial bone plates (trade name: Synthes)
- Recall Reason: The manufacturer discovered that the packaging insert for the crimping tool used with the affected products labeled them "MR Safe." However, according to current MR marking standards (ASTM F2503), metal instruments cannot be marked "MR Safe." Because the safety and compatibility of the affected products in an MRI environment have not been evaluated, and their heating, movement, or image artifacts in an MRI environment have not been tested, the safety of the affected products in an MRI environment is unknown. Implanting them during scanning could cause injury.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Synthes GmbH, distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall of craniofacial surgical instruments and bone plates. This action, reported to the National Medical Products Administration (NMPA), stemmed from an error in labeling: the packaging inserts of the crimping tools incorrectly stated the products were "MR Safe." This claim contradicts the ASTM F2503 standard, which explicitly prohibits marking metal devices as "MR Safe." The manufacturer acknowledged that the products' safety and compatibility in an MRI environment, including potential heating, movement, or image artifacts, had not been assessed. Consequently, their MRI safety remains unknown, posing a potential risk of injury to patients with implanted devices during an MRI scan. Although these medical devices hold CFDA Import Medical Device Registration Certificates, a crucial aspect of this recall is that none of the affected products were imported into or sold within China. Therefore, Johnson & Johnson Medical Companies' required actions for the Chinese market were limited to officially reporting the issue to the State Food and Drug Administration. No further assessment reports, implementation plans, or summary reports were necessary from the company for the Chinese market. However, provincial regulatory bodies were instructed to enhance their supervision and management of similar products.

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