China NMPA Product Recall - Non-cemented stem

Smith & Nephew Surgical Implants (Beijing) Co., Ltd. initiated a voluntary recall of specific batches of its uncemented handles (APL Handle, Registration No. CFDA Approval No. 20143461200), components used in cementless hip prostheses. The recall, formally reported on February 6, 2017, and published by the National Medical Products Administration (NMPA) on April 17, 2017, addresses a critical manufacturing defect. The primary issue identified was the peeling of the vacuum plasma spray coating on certain batches of the uncemented stems. This defect was discovered within the product packaging prior to patient use, indicating a significant quality control failure in the manufacturing process. The affected models include A2102, A2103, A2104, A2105, and A2106, with numerous specific batch numbers identified for recall across China. In response to this manufacturing problem, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. undertook immediate corrective actions. The company issued written notifications to all affected customers, instructing them to return any unused products. This voluntary recall aims to prevent potential patient harm associated with the compromised integrity of the surgical implants. The NMPA oversees this medical device recall event, ensuring public safety and adherence to regulatory standards for medical products.