China NMPA Product Recall - Synthetic absorbable surgical sutures

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., a subsidiary of Ethicon LLC, initiated a Class III voluntary recall of specific synthetic absorbable surgical sutures (model J359H, batch QCMDKS) on October 29, 2020. This action was reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall was prompted by an internal order system error, which resulted in a discrepancy between the product's manufacturing date and the date listed on its medical device registration certificate (No.: 20143655592).

Despite this administrative inconsistency, the company confirmed that the affected sutures were produced in adherence to all quality standards. The product's quality, performance, and safety remained unaffected, and no adverse events or patient injuries related to this issue have been reported. As a required action under the regulatory framework, Johnson & Johnson (Shanghai) proactively conducted the voluntary recall to rectify the labeling inaccuracy.

Further details concerning the affected models, specifications, and batch numbers are documented in the "Medical Device Recall Event Report Form." This recall underscores a commitment to regulatory documentation compliance, even in situations where product efficacy and patient safety are not directly compromised.