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, as announced by the National Medical Products Administration (NMPA) on December 29, 2015. The company's internal investigation revealed that certain product batches, specifically those manufactured between November 2014 and 2015 using Doosan machine tools, exhibited critical dimensional deviations. These deviations were initially discovered during routine product retesting in the production process. The primary concern stemming from these manufacturing irregularities is the significant risk that the anti-dislocation liner may not be able to be properly inserted into the acetabular shell during surgical procedures. To proactively mitigate potential patient impact and ensure surgical efficacy, Smith & Nephew made the decision to recall the affected products. This action underscores the company's commitment to product safety under the regulatory guidance of the NMPA. The specific models and specifications are detailed in the "Medical Device Recall Event Report Form."