China NMPA Product Recall - Non-absorbable surgical sutures (silk thread)

Jiahe Medical Supplies (Suzhou) Co., Ltd. has initiated a voluntary Class III recall of its non-absorbable surgical sutures (silk threads). The recall, publicly reported on November 15, 2017, was prompted by a critical quality issue identified during a regulatory inspection. On March 1, 2017, the Shanghai Yangpu District Market Supervision Administration conducted a sampling inspection, part of a broader regulatory initiative overseen by the National Medical Products Administration (NMPA). The subsequent testing by the Shanghai Medical Device Quality Supervision and Inspection Center confirmed that the thread diameter of the surgical sutures (batch number: 201609A04) did not meet the required product technical specifications. This non-conformance posed a potential risk regarding the product's intended use in suturing human tissue. In response, Jiahe Medical Supplies (Suzhou) Co., Ltd. recalled 8,500 packages of the affected product (model M6001 4-0) distributed within China, ensuring compliance and patient safety. The company submitted a formal recall report to the Jiangsu Provincial and Suzhou Municipal Food and Drug Administrations, detailing the corrective actions taken.