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 Approval No. 20143461204) under the oversight of the National Medical Products Administration (NMPA). An internal company investigation, published on December 29, 2015, identified significant dimensional deviations during retesting of certain product batches. Further inquiry revealed that products manufactured between November 2014 and July 2015, specifically those produced using Doosan machine tools, were susceptible to these deviations. This critical issue presented a risk that the anti-dislocation liner might not be able to be inserted into the acetabular shell during surgical procedures. To mitigate potential patient impact, the company implemented a comprehensive recall plan for affected models (A7143-A7149). This involved the Quality Department issuing recall notices to distributors and hospitals. All affected products, totaling 1139 units produced, were to be retrieved from the market and returned to Smith & Nephew's Shanghai warehouse, then transported to the Beijing manufacturing plant for processing. The company also committed to providing corresponding replacement products to distributors for the returned quantities.