FDA-Device2013-01-30Class II
DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.
DePuy Spine, Inc.
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.
Sold states
Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.
Affected count
10 units
Manufactured in
325 Paramount Dr, N/A, Raynham, MA, United States
Products
DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0713-2013Don't want to check this manually?
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