# China NMPA Product Recall - Spinal Surgical Implants - Thoracolumbar Fixation System

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/bf450bc2-b8ed-486d-830e-1492847bcaed/
Source feed: China

> China NMPA product recall for Spinal Surgical Implants - Thoracolumbar Fixation System by Synthes GmbH published May 04, 2015. Recall level: . The National Medical Products Administration (NMPA) published a recall notice on May 4, 2015, concer

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH of Switzerland has issued a recall for its spinal surgical implants – thoracolumbar fixation systems.
- Company Name: Synthes GmbH
- Publication Date: 2015-05-04
- Product Name: Spinal Surgical Implants - Thoracolumbar Fixation System
- Recall Reason: The manufacturer discovered that due to an error in the production process, certain models and batches of the spinal surgical implant - thoracolumbar fixation system have transverse connecting clips that cannot be securely connected to the 6mm longitudinal bar, which may lead to surgical delays.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) published a recall notice on May 4, 2015, concerning spinal surgical implants manufactured by Synthes GmbH, Switzerland. This recall was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on March 24, 2015, and applies to specific models and batches of the Thoracolumbar Fixation System (CFDA Import Permit No. 20123460787). The core issue stems from a manufacturing defect where a particular transverse connecting clip does not securely fasten to the 6mm longitudinal bar. This malfunction could result in surgical delays, potentially necessitating the re-sterilization of replacement parts or, in severe cases, a subsequent surgery to ensure adequate rotational stability. Fortunately, no revision surgeries have been reported as a direct consequence of this defect. The recalled products were distributed in regions including Australia, Hong Kong, Japan, Malaysia, and Singapore. Significantly, no affected units were imported into or sold within China. Therefore, Johnson & Johnson's Chinese entity confirmed that, apart from submitting the recall report to the NMPA, no additional actions, investigations, or reports are required for the Chinese market. The NMPA has instructed provincial food and drug administrations to enhance their oversight of similar medical devices.

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