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DePuy Spine, Inc. recalls DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which
Recalled March 27, 2013 · FDA recall Z-0960-2013 · DePuy Spine
Hazard
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck · FDA Class II
Units
1023
Sold at
Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.
Description
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Product
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
Manufacturer(s)
DePuy Spine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →