China NMPA Product Recall - Non-cemented stem (trade name: PLUS-TS)

Smith & Nephew Surgical Implants (Beijing) Co., Ltd. initiated a voluntary Level III recall for specific batches of its uncemented handles, branded as PLUS-TS, used in hip prostheses. The recall, reported on February 6, 2017, and published by the National Medical Products Administration (NMPA) on April 17, 2017, was prompted by a manufacturing process issue. It was discovered that the vacuum plasma spray coating on certain uncemented handles had peeled off while still in the product packaging, prior to use. This issue affected 4450 units sold or imported into China, encompassing various models from A2301 to A2307. A Level III recall signifies that the use of, or exposure to, the affected product is not likely to cause adverse health consequences. In response, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. implemented corrective actions by sending written notifications to all affected customers, requesting the return of any unused products. This proactive measure was taken under the regulatory framework overseen by the NMPA, previously known as the China Food and Drug Administration (CFDA), as detailed in the CFDA Approval No. 20143461197.