China NMPA Product Recall - Absorbable sutures (VICRYLPLUS)

On July 11, 2017, the National Medical Products Administration (NMPA) announced that Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall of its absorbable sutures, specifically the VICRYLPLUS brand (Registration No.: CFDA (Imported) No. 20123654478 (Revised)). This action stemmed from market supervision and spot checks, which identified that the suture diameter of the affected products did not meet their established registered product standards. While specific inspection dates were not disclosed, the non-conformance was discovered through routine regulatory oversight. The company, operating under the NMPA's framework, proactively reported the issue and commenced the recall process. The required action involves retrieving all impacted models, specifications, and batches of the non-compliant absorbable sutures from the market, as detailed in the accompanying "Medical Device Report Form." This ensures product quality and patient safety are maintained in accordance with medical device regulations.