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X Spine Systems Inc recalls Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, p
Recalled April 29, 2015 · FDA recall Z-1512-2015 · X Spine Systems
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. · FDA Class II
Units
14 units
Sold at
US Distribution to states of: KS, NV & TX.
Description
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.
Product
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.
Manufacturer(s)
X Spine Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →