# China NMPA Product Recall - Spinal surgical tools

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/23fa0650-4e58-49d4-a2b2-b386f55f0e49/
Source feed: China

> China NMPA product recall for Spinal surgical tools by Synthes GmbH published July 17, 2013. Recall level: . Synthes GmbH, represented by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a vol

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls spinal surgery tools
- Company Name: Synthes GmbH
- Publication Date: 2013-07-17
- Product Name: Spinal surgical tools
- Recall Reason: Synthe received several complaints about the tip of a bending rod breaking when surgeons attempted to bend it. Most complaints involved attempts to bend hot-worked cobalt-chromium (CoCr) rods, which are part of the Matrix system. Failure modes at the tip of the returned product included brittle fracture of the proximal tip (i.e., the tip closest to the surgeon's). The root cause was determined to be material strength and the geometry originally designed.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Synthes GmbH, represented by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall of specific spinal surgical instruments, as detailed in a National Medical Products Administration (NMPA) document dated July 17, 2013. The recalled products, registered under SFDA(I) 20111100822(Revised), were found to have a critical defect: tip breakage when bending the bending rod. Investigations revealed the root cause to be a combination of material strength deficiencies and the original design geometry, resulting in brittle fracture of the proximal tip of hot-worked cobalt-chromium (CoCr) rods used in the Matrix system. 

While this recall impacted several countries globally, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. confirmed that zero units of the affected spinal surgical instruments were ever imported or sold within China. Therefore, the company indicated no further corrective actions would be taken in China beyond reporting to the State Food and Drug Administration. Nonetheless, the NMPA mandated that provincial, autonomous region, and municipal food and drug administrations strengthen their supervision and management over similar medical device products to ensure compliance and patient safety.

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