China NMPA Product Recall - Anti-dislocation type mortis liner

On December 29, 2015, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. announced a voluntary Class III recall of certain batches of its Anti-Dislocation Ancestral Liners. This action was taken after an internal investigation revealed dimensional deviations during product retesting within the production process. The subsequent inquiry identified that medical devices manufactured between November 2014 and 2015, specifically those produced using Doosan machine tools, were likely affected by these inconsistencies. The primary concern arising from these dimensional deviations is the critical risk that the anti-dislocation liner may not properly fit or be inserted into the acetabular shell during orthopedic surgery. Such a malfunction could lead to significant complications and compromise surgical outcomes. To proactively address and prevent any potential patient impact, Smith & Nephew chose to initiate this recall. The company's immediate response, operating under the oversight of the National Medical Products Administration (NMPA), underscores its commitment to product safety and regulatory compliance. Further specific details regarding the models and specifications of the recalled medical devices are provided in the company's Medical Device Recall Event Report Form.