China NMPA Product Recall - MatrixMANDIBLE cheek remover

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.