CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

Reason: During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.

Code information: HPBB0B, HPBBWM, HPCB75, HPCCBN, HPBB0R, HPBBWP, HPCB7D, HPDBBV, HPBB28, HPBBZ7, HPCB7F, HPDBCG, HPBB2D, HPBBZF, HPCB7T, HPDBD1, HPBB2F, HPBCKH, HPCB7V, HPDBD5, HPBB4R, HPBDL9, HPCB8G, HPDBF9, HPBBV1, HPCB67, HPCBLC, HPDBGH, HPBBWG, HPCB68, HPCBM1, HPDBGK, HPBBWK, HPCB74, HPCCBM, HPDBGL

Distribution pattern: Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV, WY; Worldwide: Algeria, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Latvia, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE, and UK