FDA-Device2015-07-01Class II
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
X Spine Systems Inc
Hazard
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
Sold states
Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.
Affected count
75 units
Manufactured in
452 Alexandersville Rd, Miamisburg, OH, United States
Products
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1823-2015Don't want to check this manually?
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