China NMPA Product Recall - Bone plate screw system - straight locking plate

Zimmer Inc. initiated a global voluntary recall for specific batches of its Straight Locking Plate and Screw System, as reported by Zimmer (Shanghai) Medical International Trading Co., Ltd. to the National Medical Products Administration (NMPA) on December 14, 2015. The core issue involved significant product labeling discrepancies where the packaging for certain 11-hole Straight Reconstruction Locking Steel Plates (Product No. 00-4936-011-13, Batch No. 62968956) incorrectly contained 8-hole 3.5mm Pressure Locking Steel Plates (Product No. 00-4936-008-07, Batch No. 62968974). While the affected products were distributed internationally between February and June 2015, the company confirmed that these recalled batches were not sold or imported into China. Consequently, no related complaints or patient injuries have been reported within China. Under the NMPA's regulatory oversight, the administration mandated that all provincial, autonomous region, and municipal food and drug administrations enhance their management and scrutiny of similar medical devices to uphold product safety and accurate identification.