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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Event Detail

Event ID 64937
Product Type Devices
Status Ongoing
Recalling Firm DePuy Spine, Inc.
City Raynham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-17
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) 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 and WY; and internationally to: 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 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 HPBB0K, HPBB3C,HPCB7J, HPDBD6, HPBB0L,HPBB3D,HPCB7W,HPDBF0, HPBB0M,HPBB3F,HPDBBC,HPDBG4, HPBB0N,HPBBWH,HPDBBD,HPDBGB, HPBB0P,HPBBWJ,HPDBBK,HPDBGC,HPBB0T,HPBBWL,HPDBBL,HPDBGJ, HPBB19,HPBBZ8,HPDBBY,HPDBGM,HPBB27,HPBBZD,HPDBCD,HPDBGN, HPBB29,HPBBZN,HPDBCF, HPDBGY,HPBB2B,HPCB7B,HPDBD0,HPBB2C, HPCB7C,HPDBD3,HPBB2G,HPCB7H,HPDBD4 Class II 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. 3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways) Z-2133-2013
CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 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. HPBBZP, HPDBFZ Class II 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. 3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways) Z-2132-2013
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. 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 Class II 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. 3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways) Z-2134-2013
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