Fortex" Pedicle Screw System Continuous Radius Rod 5.5 -… recallZ-1823-2015 · X Spine Systems Inc · initiated Apr 7, 2015
Class II Terminated All recalls posted in June 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
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
FDA root cause category: Other
What the company is doing
X-Spine sent an Urgent Medical Device Recall Letter dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: 1. The affected hospital and surgeon should be notified of this recall immediately. 2. Complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately. a. Reference RMA # 5410 b. Use enclosed shipping label 3. No action should be taken with product that has been implanted. Please feel free to contact me at 800.903.0640 ext. 137.
Recall details
- Recall number
- Z-1823-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 7, 2015
- Posted by the FDA
- Jun 22, 2015
- Recalling firm
- X Spine Systems Inc
- Quantity
- 75 units
- Product code
- MNH
- FDA submissions
- K120832
- Distribution
- Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.
Product description
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
Code information (models, lots, serial numbers)
Model #: N60001068; Lot #: 2943-01; Serial #s: 46118, 46581, 47296, 47588, 47653, 48164, 48201, 48412, 49156, 49585, 49586, 49649, G22, G45, G47, G77, G83, G87X, G90X, R15, XP03, XP21, XP27, XP28, XP29 & XP32.
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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