China NMPA Product Recall - Bone Power Device Accessories

Stryker Instruments, through its agent Stryker (Beijing) Medical Device Co., Ltd., initiated a voluntary Class II recall of specific bone power device components (National Medical Device Registration Certificate 20142106119). This action, reported on April 8, 2019, and published by the National Medical Products Administration (NMPA) on April 19, 2019, addresses a potential manufacturing issue. The primary concern stems from incomplete sealing of the product. During the packaging process, a segment of the aluminum foil used for sealing was reportedly folded, which could compromise the product's sterility. The affected product is identified as the Bone Power Device Attachment, model 6125-127-100. While the recall impacts regions including the United States, Canada, France, Italy, and the Netherlands, the report indicates zero sales of the affected batches within China. In response, Stryker (Beijing) Medical Device Co., Ltd. is undertaking the voluntary recall. For affected products not imported into China, the company's action is limited to reporting to the National Medical Products Administration, with no further in-country recall measures specified due to the absence of distributed affected units in the Chinese market. The company ensures compliance with NMPA guidelines regarding product safety and quality.