China NMPA Product Recall - Small bone power device

The National Medical Products Administration (NMPA) released a notice regarding a voluntary recall initiated by Stryker Instruments, Inc., a U.S. manufacturer, affecting its small bone-powered devices. The recall was reported to the NMPA on March 26, 2014, by Stryker (Beijing) Medical Devices Co., Ltd., with the manufacturer's internal report dated March 18, 2014. The primary issue cited for the recall of these devices (Registration No.: CFDA (Imported) No. 20092101779) was the absence of crucial numerical scale markings, impacting product identification. While the recall specifically involved affected products in the USA and Singapore, Stryker (Beijing) confirmed that no units from the identified problematic batch (13280CG2) were imported or sold in China. Consequently, the company stated that no specific corrective actions or further investigations are being undertaken in China, apart from the mandatory reporting to the State Food and Drug Administration. In response, the NMPA has directed all provincial and municipal food and drug administrations to reinforce their management and oversight of similar medical devices within their jurisdictions.