China NMPA Product Recall - Hollow screw system, bone screw

The National Medical Products Administration (NMPA) issued a recall notice on August 23, 2016, concerning medical devices from Synthes GmbH, distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. This voluntary recall, reported on August 15, 2016, involved Hollow Screw Systems and Bone Screws. The main violation was that the product label information did not match the indications registered in Canada. This issue was classified as a safety notice, with no reported adverse patient effects or systemic safety concerns. Under the NMPA's regulatory framework, Synthes GmbH initiated a voluntary recall to correct product labels in the affected markets of the United States and Canada. Crucially, the document confirmed that none of the affected products were imported into or sold within China, meaning no specific corrective actions were required domestically. However, the NMPA mandated that regional food and drug administrations strengthen their supervision and management of similar products.