China NMPA Product Recall - Joint surgical tools

Howmedica Osteonics Corp., in collaboration with its Chinese responsible unit, Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary recall of specific joint surgical tools. This action was reported by the company on August 8, 2016, and publicly announced by the National Medical Products Administration (NMPA) on August 19, 2016. The recall was prompted by four reports of component separation in the Scorpio patellar assembly tool. Investigations determined that the press-fit between the bone pin and the clamping sub-component did not adhere to manufacturing specifications. These surgical instruments are utilized in various joint repair procedures, including hip, knee, and shoulder surgeries. Although the manufacturing defect was identified, no adverse patient consequences have been reported. Under the regulatory oversight of the NMPA, all affected products, which were imported under CFDA approval, are being returned to the factory as a corrective measure.