# China NMPA Product Recall - Spinal surgical instruments (trade name: SYNTHES)

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/bf85c1c8-d520-4137-b960-3884fbed9be3/
Source feed: China

> China NMPA product recall for Spinal surgical instruments (trade name: SYNTHES) by Synthes GmbH published May 04, 2015. Recall level: Class I Recall. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., representing manufacturer Synthes GmbH, init

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls spinal surgery tools.
- Company Name: Synthes GmbH
- Publication Date: 2015-05-04
- Product Name: Spinal surgical instruments (trade name: SYNTHES)
- Recall Level: Class I Recall
- Recall Reason: The manufacturer discovered that two specific models of spinal surgical tools were intended for use with 5.0mm-7.0mm screws, but the outer label and related technical manuals stated that they could be used with 4.0mm-7.0mm screws. When the affected tools are used with 4.0mm screws, there is a risk of over-drilling the cortical cavity, which could lead to screw dislodgement or loosening, although no related adverse events or complaints have been received to date.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., representing manufacturer Synthes GmbH, initiated a voluntary Class I recall of specific spinal surgery tools, as reported to the National Medical Products Administration (NMPA) on May 4, 2015. The core issue involved a critical labeling error: two models of spinal surgery instruments, designed for use with 5.0mm-7.0mm screws, were incorrectly described on their outer labels and in technical manuals as suitable for 4.0mm screws. This discrepancy created a risk of excessive cortical drilling when the tools were used with 4.0mm screws, potentially leading to screw dislodgement or loosening in patients. Despite no reported adverse events or complaints, the serious nature of the potential patient harm necessitated this high-level recall under the NMPA's regulatory framework. The recall affected 321 units, with 301 units sold and 308 consigned in China. Required actions include updating filing information with the NMPA and notifying all affected distributors and hospitals to ensure awareness and mitigate risks.

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