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DePuy Spine, Inc. recalls DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.
Recalled January 30, 2013 · FDA recall Z-0708-2013 · DePuy Spine
Hazard
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head · FDA Class II
Units
24 units
Sold at
Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.
Description
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Product
DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.
Manufacturer(s)
DePuy Spine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →