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.
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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