China NMPA Product Recall - Hip prosthesis

The National Medical Products Administration (NMPA) issued an index, JGXX-2017-10412, on May 17, 2017, regarding a voluntary recall by Howmedica Osteonics Corp. for specific hip prostheses. The recall was prompted by customer complaints indicating that product model 0580-1-440, batch number G6106543, lacked essential deep markings. This product defect was reported by Stryker (Beijing) Medical Devices Co., Ltd., which distributes the devices. The manufacturer confirmed that none of the affected products were imported into or sold within China. The recall primarily impacts regions including Japan, Canada, India, and the United Kingdom, where the product was sold. As a regulatory measure, all provincial, autonomous region, and municipal food and drug administrations in China have been instructed to strengthen their management and oversight of similar medical devices. Stryker (Beijing) Medical Devices Co., Ltd. reported the issue to the State Food and Drug Administration but stated no further actions would be taken by them given the absence of sales in China. The report detailing corrective actions was filed on April 20, 2017.