# China NMPA Product Recall - Locking plate

Source: https://www.keypedia.com/records/china_product_recall/synthes-gmbh/01bbec19-8e16-4c0c-8938-213fd552f270
Source feed: China

> China NMPA product recall for Locking plate by Synthes GmbH published April 13, 2016. Recall level: . The National Medical Products Administration (NMPA) published a recall notice on April 13, 2016, reg

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls locking plates
- Company Name: Synthes GmbH
- Publication Date: 2016-04-13
- Product Name: Locking plate
- Recall Reason: The affected products may have been etched with the wrong model number. For example, a right-angled product might have been etched with the model number for a left-angled product. Before surgery, the user may discover a mismatch between the product and the structure within the tray/mold. If this is not discovered upon entering the operating room, the surgeon can use the bone plate normally as long as it conforms to the anatomical structure. However, if the surgeon requests a specific model of bone plate, it may be discovered that the plate structure does not match the expected anatomical structure, potentially causing surgical delays due to the need to replace it with a spare.
- 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 April 13, 2016, regarding Locking Bone Plates manufactured by Synthes GmbH, a subsidiary of Johnson & Johnson. The recall, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on March 24, 2016, was initiated due to incorrect model labeling on the affected products (Registration Certificate No.: 20163460077). The primary issue identified was that certain Locking Bone Plates (models 04.115.150, 04.115.151, batch numbers 9678747, 9678750), intended for internal fixation of distal radius fractures, may have been etched with an incorrect product model number, such as a right-angled plate being labeled as a left-angled one. This mislabeling could potentially lead to discovery before or during surgery, causing surgical delays if a replacement plate is needed.

Under the NMPA's regulatory framework, provincial, autonomous region, and municipal food and drug administrations were requested to strengthen supervision of such medical devices. Crucially, the document explicitly states that none of the affected products were imported into or sold within China. Therefore, no specific corrective actions were required from Synthes GmbH or Johnson & Johnson within the Chinese market, though the recall did affect regions like Australia, Singapore, UAE, Czech Republic, and Germany.

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