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 hip prosthesis, marketed under the trade name PLUS-TS. The recall, reported on February 6, 2017, and published by the National Medical Products Administration (NMPA, formerly CFDA) on April 17, 2017, addresses a critical manufacturing defect. The primary issue identified was the peeling of the vacuum plasma spray coating on certain uncemented stems during the production process. This defect was discovered in the product packaging prior to use, raising concerns about the product's integrity and performance. The affected products, totaling 4450 units across various models and batch numbers, were distributed within China. In response, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. has taken corrective action by notifying all affected customers in writing and requesting the return of all unused recalled products. This proactive measure aligns with regulatory requirements for managing medical device quality and safety under NMPA guidelines, aiming to prevent potentially compromised implants from being used in patient care.