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

On February 7, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Smith & Nephew Surgical Implants (Beijing) Co., Ltd. The recall pertains to their uncemented handles, identified by the trade name PLUS-TS, which are components of hip prostheses. The primary issue identified was a manufacturing process defect leading to the peeling of the vacuum plasma spray coating from specific batches of these handles. This problem was attributed to improper packaging of the product before use, with the coating detachment observed within the product packaging prior to application.

Smith & Nephew Surgical Implants (Beijing) Co., Ltd. promptly informed affected customers in China, encompassing 4450 units across models A2301 through A2307. The required actions involve issuing written notifications to all impacted customers and retrieving all unused, affected products from distribution. This recall underscores the company's adherence to regulatory frameworks enforced by the NMPA (formerly CFDA) to ensure product quality and patient safety in medical devices.