China NMPA Product Recall - Non-cemented stem

Smith & Nephew Surgical Implants (Beijing) Co., Ltd. initiated a voluntary Class III recall, officially reported to China's National Medical Products Administration (NMPA) on November 16, 2016, and publicized on November 23, 2016. The recall targets specific batches of uncemented handles, part of their Cementless Hip Prosthesis system (CFDA Approval No. 20143461200), designed for hip replacement procedures. The core issue stemmed from a manufacturing process problem leading to the peeling of the vacuum plasma spray coating on these uncemented stems. This defect was identified when detached coating material was found inside the product packaging before the devices could be used. Affected products include models A2104 and A2105, with 169 units distributed in China. Key batch numbers involved are 16AB00351, 16CB00614, 16AB00426, 16AB00562, and 16AB00353. Under the regulatory framework of the NMPA, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. undertook immediate corrective actions. The company dispatched written notifications to all affected customers, directing them to return any unused products. This proactive measure ensures the removal of potentially compromised medical devices from the supply chain, upholding product integrity and patient safety, even for issues classified as unlikely to cause adverse health consequences.