China NMPA Product Recall - Hip prosthesis

The National Medical Products Administration (NMPA) announced a Class III voluntary recall of hip prostheses manufactured by Smith & Nephew, Inc. and distributed by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. The recall, published on June 14, 2017, stemmed from an incorrect packaging issue reported on May 15, 2017. The primary violation involved a significant labeling error: the outer English packaging for product model 71302804 incorrectly described a 28mm diameter head with a +4mm offset, while the actual device inside was model 71303200, a 32mm diameter head with a +0mm offset. This discrepancy posed a risk of product misidentification, potentially leading to the use of an improperly sized prosthesis. The regulatory framework under which this action was taken is the NMPA's oversight for medical device safety. As a required action, Smith & Nephew, Inc. initiated the voluntary recall of the affected hip prostheses (Registration Certificate No. 20153463804). Notably, the official report indicated that zero affected products were sold in China, confirming that this specific recall did not impact the Chinese market.