China NMPA Product Recall - Screw system, locking nail plate system

The National Medical Products Administration (NMPA) published a recall event report regarding medical devices manufactured by DePuy Orthopaedics, Inc., and distributed by its Chinese subsidiary, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The initial report was dated August 31, 2010, with a corrective action summary reported on July 21, 2017. The recall specifically addressed Screw Systems and Locking Plate Systems, which are essential for fracture treatment and reconstruction surgery. The core issue involved certain DePuy trauma products that were mistakenly labeled as "Made in China" but were, in fact, imported items, leading to their erroneous shipment into the Chinese market. These products were regulated under NMPA Medical Device (Imported) No. 2009 3460128 and CFDA Medical Device Approval No. 2008 3461609. A total of 1370 affected units had been sold within China. Under the NMPA's regulatory oversight, the prescribed corrective action mandated that all identified products be promptly returned to the DePuy manufacturing facility to rectify the labeling and distribution discrepancy.