Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An… recallZ-1512-2015 · X Spine Systems Inc · initiated Mar 11, 2015
Class II Terminated All recalls posted in April 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from X Spine Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The firm, X-spine Systems, Inc., sent an "Urgent Medical Device Recall" letter dated March 19, 2015 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to notify affected hospital and surgeon of the recall immediately; complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately via mail: 725 Alexandersville Road, Miamisburg OH 45342-RMA #5288; and No action should be taken with product that has been implanted. Please contact customer service at 800.903.0640 or email [email protected] with any questions.
Recall details
- Recall number
- Z-1512-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 11, 2015
- Posted by the FDA
- Apr 22, 2015
- Recalling firm
- X Spine Systems Inc
- Quantity
- 14 units
- Product code
- MNH
- FDA submissions
- K120832
- Distribution
- US Distribution to states of: KS, NV & TX.
Product description
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.
Code information (models, lots, serial numbers)
Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*
Other devices under the same FDA submission
5 devices cleared under K120832 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Fortex Pedicle Screw System N60001073Xtant Medical Holdings, Inc. · Orthosis, spondylolisthesis spinal fixation2 reports
- Fortex Pedicle Screw System X022-0042Xtant Medical Holdings, Inc. · Orthosis, spondylolisthesis spinal fixation2 reports
- Fortex Pedicle Screw System X022-0096Xtant Medical Holdings, Inc. · Orthosis, spondylolisthesis spinal fixation2 reports
- Fortex Pedicle Screw System X070-0011Xtant Medical Holdings, Inc. · Orthosis, spondylolisthesis spinal fixation2 reports
- Fortex Pedicle Screw System X022-0095Xtant Medical Holdings, Inc. · Orthosis, spondylolisthesis spinal fixation1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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