# China NMPA Product Recall - MatrixMANDIBLE cheek remover

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/d03069af-6525-49ce-9e59-5d5b6d13feab/
Source feed: China

> China NMPA product recall for MatrixMANDIBLE cheek remover by Synthes GmbH published February 15, 2015. Recall level: Level 2 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 craniofacial surgical instruments.
- Company Name: Synthes GmbH
- Publication Date: 2015-02-15
- Product Name: MatrixMANDIBLE cheek remover
- Recall Level: Level 2 Recall
- Recall Reason: The manufacturer has discovered that certain batches of MatrixMANDIBLE cheek pullers may have springs that are malfunctioning and/or corroded due to the use of incorrect raw materials. If affected products fail to function during surgery and require replacement, it could harm the patient, including delays in the procedure. If corroded material from the spring falls into the wound site during use and is not promptly removed during rinsing, it could cause adverse tissue reactions and/or infection. No related complaints have been received in China.
- 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 Class II voluntary recall of specific Craniofacial Surgical Instruments, namely the MatrixMANDIBLE cheek retractors, on February 15, 2015. The manufacturer identified that springs in certain batches of these instruments could malfunction or corrode due to the use of incorrect raw materials.

The primary concerns associated with this issue include potential delays in surgical procedures if an instrument fails and the risk of adverse tissue reactions or infections if corroded material enters the surgical wound and is not thoroughly removed. The affected products, identified under model 397.232, are part of the SYNTHES craniofacial implant system. There have been no reported patient complaints related to these issues in China. The recall was published by the National Medical Products Administration (NMPA).

Corrective actions require notifying all affected distributors and users to immediately cease using the compromised instruments and arrange for their return. Recalled products are to be either returned to the manufacturer or destroyed locally, ensuring their complete removal from the supply chain and adherence to product quality and patient safety standards.

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