China NMPA Product Recall - Multiaxial pedicle screw fixation system (trade name: SYNTHES) - Spinal surgical implant - Thoracolumbar fixation system - Spinal pedicle screw fixation system

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Level I recall for specific batches of its Multiaxial Pedicle Screw Fixation System (SYNTHES) spinal surgical implants. The recall, reported on January 11, 2015, and published by the National Medical Products Administration (NMPA) on December 9, 2015, stemmed from the manufacturer, Synthes GmbH, discovering a manufacturing deviation. The issue involved five batches of products potentially produced with sandblasted balls having a shorter head length than specified. This reduced sandblasting area could decrease screw head friction, potentially affecting the resistance to movement or slippage of the universal screw within the internal fixation structure. The affected products, designed for posterior internal fixation of the thoracic, lumbar, and sacral spine, were imported to and sold in China, among other regions. To date, no complaints or adverse events related to this specific issue have been reported globally or in China. The required actions include notifying affected customers to cease using and return the impacted products for either manufacturer return or local destruction. Prophylactic removal of implanted screws is not recommended for patients; instead, standard monitoring guidelines should be followed.