China NMPA Product Recall - Femoral head impactor

Smith & Nephew, Inc. ASD Division initiated a voluntary recall of specific batches of its femoral head striking devices, as reported by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. The recall, detailed in an NMPA document published on July 25, 2012, stems from a critical manufacturing defect. It was discovered that the plastic head of these devices was produced using incorrect material, specifically polyethylene instead of the required polypropylene. This material mismatch caused the femoral head striking devices to melt during high-temperature and high-pressure sterilization, rendering them unusable and posing potential risks in surgical settings. Upon discovery, corrective actions were swiftly implemented. Eight affected products at the distributor's location were immediately removed from service, returned to Smith & Nephew's warehouse, and replaced with compliant products. Additionally, twenty-one units remaining in stock were isolated and also replaced. All recalled affected products were subsequently returned to Smith & Nephew's ICAB Orthopedics division for proper processing. This proactive recall, with a report date of July 9, 2012, aimed to ensure patient safety and product integrity by addressing the material non-conformance. The National Medical Products Administration advised provincial administrations to strengthen supervision over such medical devices.