China NMPA Product Recall - Tendon Stripper

The National Medical Products Administration (NMPA) issued a notice concerning a voluntary recall initiated by Smith & Nephew, Inc. Endoscopy Division for certain batches of its Tendon Stripper tendon separators. The primary issue identified was that the product's shaft material did not meet Smith & Nephew's internal SNE 416 specification, potentially leading to surface oxidation and roughening. While the NMPA initially published this recall information in October 2011, a detailed recall report from Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. documented corrective actions as of September 1, 2017.

Under the NMPA's regulatory framework, provincial and municipal food and drug administrations were directed to strengthen supervision. The required actions include an immediate halt to the sale of 18 clinically unused products. For units already shipped to hospitals, distributors are tasked with informing facilities and facilitating the return of affected products to Smith & Nephew's Shanghai warehouse. These units will be replaced with compliant products and subsequently returned to the company's US Endoscopy division for processing. Smith & Nephew estimates completing the global recall within six months, acknowledging that the risk is controllable as hospitals typically inspect surgical tools before use.