China NMPA Product Recall - Anti-dislocation type mortis liner

Smith & Nephew Surgical Implants (Beijing) Co., Ltd. initiated a voluntary Class III recall of its Anti-Dislocation Ancestral Liners (CFDA Registration No. 20143461204) following an internal investigation. The company discovered dimensional deviations in certain product batches manufactured between November 2014 and 2015 using Doosan machine tools. This manufacturing defect presents a critical risk: the anti-dislocation liner may not properly insert into the acetabular shell during surgical procedures, potentially impacting patient safety and surgical outcomes. To mitigate these potential impacts, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. proactively decided to recall all affected products. The recall was reported and managed under the regulatory oversight of the National Medical Products Administration (NMPA), ensuring adherence to medical device safety standards. Detailed information regarding specific affected product models and specifications is available in the accompanying "Medical Device Recall Event Report Form".