Z-1823-2015Class II

Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville...

Name: Z-1823-2015 Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville...
Creator: X Spine Systems Inc
Published: 2015-04-07
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2015-04-07 / Terminated

FDA source

X Spine Systems Inc began a recall of Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400 on 2015-04-07. FDA classified it as Class II and gives the reason as "The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1823-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-07
Posted: 2015-06-22
Terminated: 2015-10-01
Recalling firm: Xtant Medical Holdings, Inc.
Product: Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
Product code: MNH Orthosis, Spondylolisthesis Spinal Fixation
Reason for recall: The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
FDA root cause: Other
Action: 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.
Quantity in commerce: 75 units
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1823-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1823-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-22

Product code MNH

K120832Class IIFortex Pedicle Screw SystemX-Spine Systems, Inc. / cleared 2012-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)