China NMPA Product Recall - Knotless anchor bolts, OSTEORAPTOR™, dual fixing screw system

The National Medical Products Administration (NMPA) reported a voluntary recall initiated by Smith & Nephew, Inc. Endoscopy Division, as communicated by its Chinese subsidiary, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., on August 8, 2013. The recall primarily concerns knotless thread anchors, OSTEORAPTOR™ products, and specific dual fixation screw systems (CFDA (Imported) 2013 No. 3461648) due to packaging integrity issues. The main violation was the discovery of pinholes or minor cracks on the primary packaging bags, which could compromise the sterile barrier of the products.

This global recall did not affect products actively marketed or sold to patients in China. In China, 307 pieces were imported exclusively as samples for product registration testing. Of these, 37 pieces were consumed during testing, and 270 remain in stock. These items were distinctly labeled for "Non-clinical use" and were not distributed for commercial purposes. The regulatory framework involves the NMPA's oversight of medical devices. As a required action, the remaining affected samples will continue to be stored in the sample warehouse. Furthermore, the NMPA has directed all provincial food and drug administrations to enhance their supervision and management of similar medical devices to uphold product safety standards.