FDA-Device2015-04-29Class II
Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
X Spine Systems Inc
Hazard
One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
Sold states
US Distribution to states of: KS, NV & TX.
Affected count
14 units
Manufactured in
452 Alexandersville Rd, Miamisburg, OH, United States
Products
Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1512-2015Don't want to check this manually?
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