China NMPA Product Recall - Laparoscopic surgical instruments (trocars)

Hangzhou Tonglu Medical Optical Instrument Co., Ltd. initiated a Class III voluntary recall for its Laparoscopic Surgical Instruments (Puncture Devices) on January 17, 2019. This action followed a national medical device supervision and spot check conducted on May 24, 2018, which revealed the product's hardness index failed to meet established requirements. The primary issue was traced to the company's internal quality control, where a worn standard block on their hardness tester resulted in inaccurate calibration and excessively high hardness readings for a specific batch produced on May 3, 2018.

Operating under the regulatory framework of the National Medical Products Administration (NMPA) and the local Tonglu County Market Supervision Administration, the company undertook several required corrective actions. These included immediately ceasing sales and production of the affected devices. Furthermore, the company reconfigured new hardness testers and sample blocks, and implemented adjustments to the heat treatment process for the puncture devices. Importantly, none of the affected products from this batch entered the commercial market, effectively making this an internal recall to prevent distribution. Production and sales will only resume after regulatory authorities confirm the complete resolution of the hardness testing issue and verify the quality of all other batches.