China NMPA Product Recall - Joint surgical tools

Howmedica Osteonics Corp., in collaboration with Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary Class III recall of its joint surgical instruments. This action was reported to the National Medical Products Administration (NMPA) on August 31, 2016, and publicly announced on September 14, 2016. The recall pertains to specific joint surgical instruments (CFDA (Imported) 2013 No. 1104594), which are utilized in various arthroplasty procedures for hip, knee, shoulder, elbow, and wrist. The primary issue identified is the potential for the stud between the stud and handle shaft assembly of the acetabular cup inserter to gradually protrude over time. This defect may lead to threaded sections appearing from the acetabular mold or implant dome. The recall affects 217 units distributed in China, as part of a global recall. To address this, Howmedica Osteonics Corp. is required to notify all affected distributors, instructing them to return the impacted product batches to the manufacturer for appropriate disposal, thereby mitigating any potential risks associated with the faulty instruments.