China NMPA Product Recall - Bone Power Device Accessories

Stryker Instruments, through its Chinese affiliate Stryker (Beijing) Medical Device Co., Ltd., initiated a voluntary recall for its Bone Power Device Accessories, registered under National Medical Device Registration Certificate 20142106119. The recall, formally reported on August 24, 2016, and published by the National Medical Products Administration (NMPA) on September 30, 2016, addresses a critical manufacturing defect. The primary issue identified was incorrect manufacturing leading to a damaged aseptic barrier, specifically a flaw in the sterile packaging's seal. This compromises the sterility of the accessories, designed for bone tissue cutting and drilling. While the recall affects markets like the United States, Australia, and parts of Europe, Stryker confirmed that no affected products (batch number 16029017) were imported or sold within China. Consequently, Stryker (Beijing) Medical Device Co., Ltd. stated no further corrective actions would be undertaken in China beyond reporting to the NMPA. Under its regulatory framework, the NMPA has instructed provincial and municipal food and drug administrations to enhance oversight of similar medical devices to safeguard public health.