China NMPA Product Recall - Tendon and ligament fixation anchors

Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall of its tendon and ligament fixation anchors, published on March 30, 2020, through the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall was prompted by an identified issue where excessive space between the medical device and its internal packaging could allow for increased product movement. This movement posed a risk that the protective cap at the product's tip might shift and potentially puncture the sterile packaging. A compromised sterile barrier could render the device unsuitable for its intended surgical application, although the company noted that this specific defect is easily detectable prior to use. This proactive measure by Smith & Nephew demonstrates their commitment to patient safety and adherence to the regulatory framework established by the NMPA. The required action involves removing all affected batches of these anchors from the market to mitigate any potential risks, with specific models and batches detailed in the accompanying "Medical Device Recall Event Report Form."