China NMPA Product Recall - Synthetic Absorbable Surgical Suture PDS II Polydioxanone Monofilament

The National Medical Products Administration (NMPA) announced on February 28, 2022, a Class III voluntary recall initiated by Johnson & Johnson International c/o European Logistics Centre. This recall pertains to specific models and batches of their PDS II Polydioxanone Monofilament synthetic absorbable surgical sutures. The issue was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., identifying a critical manufacturing defect: cracks at the connection point between the needle and the suture.

This structural integrity problem in a surgical product poses potential risks to patient safety during medical procedures, necessitating immediate action. The regulatory framework under which this recall is conducted is governed by the NMPA, which mandates manufacturers to address product deficiencies promptly. As a voluntary Class III recall, it indicates that the defect is unlikely to cause serious adverse health consequences but still requires corrective action to prevent potential issues.

The required action involves the immediate removal of all affected synthetic absorbable surgical suture PDS II Polydioxanone Monofilament products (Registration Certificate No.: 20153023327) from the market. Johnson & Johnson is obligated to provide comprehensive details regarding the specific models, specifications, and batch numbers impacted by this recall through a "Medical Device Recall Event Report Form," ensuring thorough identification and containment of the faulty products. This measure underscores the commitment to maintaining medical device quality and patient safety within the NMPA's regulatory purview.