China NMPA Product Recall - Metal bone plate system

On April 1, 2015, Zimmer Medical (Shanghai) International Medical Trading Co., Ltd., representing manufacturer Zimmer Inc., initiated a voluntary Class II recall of specific Metal Bone Plate Systems. This action was reported to the National Medical Products Administration (NMPA) in China. The primary issue identified was a packaging discrepancy where the original packaging for screws with batch number 62629432 was confused with that of screws with batch number 62628759. This confusion had the potential to lead to incorrect product identification for these critical medical devices.

The affected products, including specific cancellous bone screws used in Metal Bone Plate Systems and Periarticular Metal Bone Plate Systems, are indicated for internal fixation of various fractures, such as pelvic, limb shaft, and periarticular fractures. The recall involved products with part numbers 00-4840-020-00 and 00-2347-022-14. A total of 225 units manufactured or imported into China, along with an additional 60 pieces, were impacted by this global recall. As the required corrective action, all identified affected products have been successfully returned to the manufacturer, Zimmer Inc., ensuring the resolution of the packaging issue and mitigating potential risks associated with the misidentification of these medical devices.