China NMPA Product Recall - Absorbable soft tissue injury suture anchors, absorbable bone anchors with sutures

On May 22, 2023, DePuy Mitek, a manufacturer of medical devices, initiated a voluntary Class III recall for specific batches of its absorbable soft tissue injury suture anchors and sutured absorbable bone anchors. This action was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall addresses a significant safety concern related to the no-knot anchor inserter component of these devices. It was identified that applying bending force to the inserter, or using such force to drive it during surgical procedures, carries a risk of damaging the inserter tip. Such damage could lead to the tip breaking off, posing a potential hazard to patients and impacting the integrity of the procedure. This recall falls under the regulatory framework of the National Medical Products Administration (NMPA). As a required action, DePuy Mitek is voluntarily withdrawing all affected models, specifications, and batches from the market. The company is committed to ensuring product safety and minimizing any potential risks to patients and healthcare professionals. Comprehensive details, including specific product identifiers and batch numbers, are provided in the "Medical Device Recall Event Report Form" attached to the official communication. This measure underscores the company's commitment to quality assurance and patient well-being in response to identified product deficiencies.