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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Product Detail

Product Description 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
Recall Number Z-2133-2013
Classification Class II
Product Distributed Qty 3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)
Reason For Recall 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.

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.