Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Xpress System Pedicle Screw Assembly Recalled by X Spine Systems Inc Due to One lot of instruments have etched on the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact X Spine Systems Inc directly.
Affected 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.
Quantity: 14 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 3 states: KS, NV, TX
About X Spine Systems Inc
X Spine Systems Inc has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report