Z-1512-2015Class II

Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting...

Name: Z-1512-2015 Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting...
Creator: X Spine Systems Inc
Published: 2015-03-11
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2015-03-11 / Terminated / root cause: manufacturing process

FDA source

X Spine Systems Inc began a recall of Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap... on 2015-03-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1512-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-11
Posted: 2015-04-22
Terminated: 2015-10-21
Recalling firm: Xtant Medical Holdings, Inc.
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.
Product code: MNH Orthosis, Spondylolisthesis Spinal Fixation
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 14 units
Distribution: US Distribution to states of: KS, NV & TX.
Product codes and lots: Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1512-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1512-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-22

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)