# China NMPA Product Recall - Spinal surgical implants - anterior cervical locking plate screws

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/f2db46be-97af-42b4-9be9-903f8aa7cedc/
Source feed: China

> China NMPA product recall for Spinal surgical implants - anterior cervical locking plate screws by Synthes GmbH published December 22, 2014. Recall level: Level II. On December 22, 2014, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting under the overs

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its spinal surgery implant – anterior cervical locking plate screws.
- Company Name: Synthes GmbH
- Publication Date: 2014-12-22
- Product Name: Spinal surgical implants - anterior cervical locking plate screws
- Recall Level: Level II
- Recall Reason: The manufacturer received one complaint from China regarding a 4.0mm TI leather-type expansion screwdriver (450.138, not 14mm, batch number 8395713) with an incorrect length. The complaint assessment revealed that the screw pitch did not conform to the specifications in the 450.138 product drawing. However, the screw's 16mm pitch and thread geometry were consistent with the 450.133 product drawing. A 16mm screw conforming to the drawing should be anodized to a purplish-red (purple) color, but the complained screw was gold; this indicates that the screw used the surface treatment process of part number 450.138 (batch number 8395713), and the confusion occurred before the anodizing process. Users can visually distinguish the different thread shapes. Furthermore, for unsterilized screws, according to the screw holder design in the screw case, a 16mm screw may protrude when placed in the area designated for a 14mm screw. Use of this defective device may result in bone injury, soft tissue/intervertebral disc injury, spinal cord/meningeal injury, and surgical delay. To date, only one complaint has been received. The user discovered the error after connecting before the surgery, and the error was not used by the patient or caused any delay in the surgery.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: On December 22, 2014, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting under the oversight of China's National Medical Products Administration (NMPA), initiated a voluntary Class II recall. The recall, impacting products manufactured by Synthes GmbH, concerned specific Anterior Cervical Locking Plate Screws used in spinal surgery implants. The core issue involved a manufacturing discrepancy for 4.0mm TI cortical bone expansion head screws (specification 450.138, batch number 8395713). It was discovered that these screws, intended to be 14mm, were incorrectly manufactured at 16mm, and their pitch and thread geometry did not conform to the specified product drawing but rather matched a different product (450.133). Additionally, a color inconsistency indicated a mix-up prior to the anodizing process. The use of these defective devices posed potential risks, including bone, soft tissue, or spinal cord injury, and could lead to surgical delays. Fortunately, only one complaint was received, and the error was identified pre-operatively, preventing any patient harm or surgical delay. The recall specifically targeted 40 units of model/specification 450.138, batch number 8395713, which had been imported and sold in China. Affected screws could be visually distinguished by their incorrect thread shape or by protruding from their designated screw holder.

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