# China NMPA Product Recall - Schanz nails, orthopedic surgical instruments (trade name: SYNTHES)

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/fcc1e4aa-0929-4e09-b83b-5a78a1f8e0c7/
Source feed: China

> China NMPA product recall for Schanz nails, orthopedic surgical instruments (trade name: SYNTHES) by Synthes GmbH published December 02, 2014. Recall level: Class II Recall. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. and its manufacturer, Synthes GmbH, initiated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling Schanz nails and orthopedic surgical instruments.
- Company Name: Synthes GmbH
- Publication Date: 2014-12-02
- Product Name: Schanz nails, orthopedic surgical instruments (trade name: SYNTHES)
- Recall Level: Class II Recall
- Recall Reason: According to the current ASTM F2503 testing standard, metal instruments cannot be labeled "MR Safe." However, some markings or etchings on CMF mandibular external fixator systems I and II contain the words "MR Safe," thus requiring some changes to the labeling.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. and its manufacturer, Synthes GmbH, initiated a Class II voluntary recall of specific Schanz screws and orthopedic surgical instruments on December 2, 2014. This action was prompted by a labeling inaccuracy identified against the current ASTM F2503 testing standard. The primary issue involved certain CMF mandibular external fixator systems I and II, which were labeled or etched with the designation "MR Safe." However, under the updated ASTM F2503 standard, metal instruments are not permitted to carry this "MR Safe" label. This constitutes a significant labeling discrepancy, as the presence of such a label could provide misleading information regarding the device's compatibility within a Magnetic Resonance (MR) environment. Overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Food and Drug Administration, the recall affects various models and all batch numbers of the implicated products, which were imported into China and other international regions. The required action is a voluntary recall of the affected products to implement necessary label changes, ensuring accurate information for users and compliance with regulatory standards.

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