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DePuy Mitek, Inc., a Johnson & Johnson Co. recalls Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Co
Recalled July 11, 2012 · FDA recall Z-1938-2012 · DePuy Mitek, Inc., a Johnson & Johnson
Hazard
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles · FDA Class II
Units
704 units
Sold at
Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, and UK.
Description
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Product
Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Manufacturer(s)
DePuy Mitek, Inc., a Johnson & Johnson Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →