China NMPA Product Recall - Bone dynamic system

The National Medical Products Administration (NMPA) announced on July 11, 2016, details regarding a voluntary recall initiated by Stryker Instruments concerning its Bone Power System (Registration Certificate No.: CFDA (Imported) 2012 No. 2104407). The recall was formally reported by Stryker (Beijing) Medical Devices Co., Ltd. on June 22, 2016. The primary concern prompting this action is the potential for rust or corrosion to develop in the grinding head component of the bone power system, a device utilized for critical surgical tasks such as cutting, drilling, and enlarging holes in human bones.

Under the NMPA's regulatory framework, specific affected models and batch numbers were identified. However, Stryker (Beijing) confirmed that no units of the recalled Bone Power System were ever imported into or sold within the Chinese market. Therefore, the company's required actions in China were limited to reporting the recall to the State Food and Drug Administration (now NMPA), with no further domestic corrective measures deemed necessary due to the absence of affected products. Despite this, the NMPA mandated that provincial and municipal food and drug administrations enhance their oversight and management of similar medical devices to safeguard public health. The recall's primary impact was felt in international regions including the USA, Canada, and Europe.