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

Smith & Nephew Surgical Implants (Beijing) Co., Ltd. initiated a voluntary Level III recall of its uncemented hip prosthesis stems, marketed under the trade name PLUS-TS (CFDA Approval No. 20143461197). This action was reported on February 6, 2017, and publicly announced by the National Medical Products Administration (NMPA) on April 17, 2017. The primary reason for the recall was a manufacturing process deficiency that caused the vacuum plasma spray coating on specific batches of these implants to peel off. This critical product defect was discovered in the packaging before the products were used. In response, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. promptly issued written notifications to all affected customers in China, instructing them to return any unused products from the identified faulty batches. This measure aimed to prevent the use of potentially compromised medical devices and ensure patient safety. The recall encompasses 4450 units distributed across various models and batch numbers within China.