China NMPA Product Recall - Hip prosthesis

Smith & Nephew, Inc. has initiated a voluntary Class III recall of specific hip prostheses, as reported to China's National Medical Products Administration (NMPA) on November 24, 2017. The recall stems from a manufacturing error where a 36mm-3 femoral head was incorrectly laser-etched as 36mm+4 and subsequently placed within packaging designated for a 36mm+4 femoral head. This mislabeling and packaging error affects product models 71303603/713604 and related batches, posing a risk of incorrect component implantation.

This voluntary action by Smith & Nephew, Inc. is conducted under the oversight of the NMPA, referencing National Medical Device Registration Certificate 20153463804. While the recall was reported through the NMPA framework, the document explicitly states that this particular recall does not impact the Chinese market. Affected products were identified in regions such as Russia. The company is responsible for managing the recall process for these mislabeled hip prostheses.