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X Spine Systems Inc recalls Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisbur

Recalled July 1, 2015 · FDA recall Z-1823-2015 · X Spine Systems

Hazard
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. · FDA Class II
Units
75 units
Sold at
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.

Description

The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.

Product
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
Manufacturer(s)
X Spine Systems Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

X Spine Systems Inc recalls Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisbur | RecallWatchUSA