China NMPA Product Recall - Bone Power Device Accessories

The National Medical Products Administration (NMPA) published a report on October 8, 2016, detailing a voluntary recall initiated by Stryker Instruments for its bone power device accessories. Stryker (Beijing) Medical Device Co., Ltd., the product's distributor and responsible unit in China, reported the issue on August 24, 2016. The central problem identified was a manufacturing defect in the sterile packaging, specifically an incorrect seal between the upper and lower layers. This flaw compromises the aseptic barrier of the device, which is registered under National Medical Device Registration Certificate 20142106119. The recall primarily affects products distributed in several countries, including the United States, Australia, New Zealand, France, and Italy, specifically batch number 16029017. Crucially, Stryker confirmed that none of the affected products were imported or sold within China. Therefore, beyond submitting the required report to the State Food and Drug Administration, Stryker (Beijing) Medical Device Co., Ltd. is not required to undertake additional corrective actions related to product retrieval within China. Under the NMPA's regulatory oversight, provincial and local food and drug administrations are instructed to strengthen their surveillance of similar medical devices.