China NMPA Product Recall - Hemiarthroplasty component (trade name: Tandem)

Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for specific models (71324038-71324054) of its Hemi-Hip Joint Prosthesis Component, known as Tandem. Reported on September 8, 2016, and publicized by the National Medical Products Administration (NMPA) on December 7, 2016, the recall stems from a manufacturing error. The dimension of the clasp groove position on affected products exceeded design specifications, compromising product integrity. This defect could lead to significant functional complications, including the inability to assemble the prosthesis during surgical preparation, a tight bulbous head after assembly, or, in rare instances, dislocation within weeks following surgery. Approximately 1001 affected units were sold in China, out of 1013 produced globally. Under the NMPA's regulatory oversight, the required action for the company is to notify customers to return all unused affected products to prevent potential patient harm and ensure medical device safety.