Z-1884-2017Class II

5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags...

Name: Z-1884-2017 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags...
Creator: Xtant Medical Inc
Published: 2017-04-12
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2017-04-12 / Terminated / root cause: labeling and UDI

FDA source

XTANT MEDICAL INC began a recall of 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia... on 2017-04-12. FDA classified it as Class II and gives the reason as "The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1884-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-12
Posted: 2017-04-27
Terminated: 2017-08-16
Recalling firm: Xtant Medical Holdings, Inc.
Product: 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a pedicle screw construct. Indications for Use: The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Product code: MNH Orthosis, Spondylolisthesis Spinal Fixation
Reason for recall: The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: XTANT sent an Urgent Medical Device Removal letter dated 4/12/2017 to customers with a Return Response Acknowledgement and Receipt form. The letter identified the affected product, problem and actions to be taken. For questions call 406-570-7028.
Quantity in commerce: 97 units
Distribution: Worldwide distribution - US Nationwide in the states of: AZ, CA, CT, GA, LA, NV, OH, TX and in the country of Mexico.
Product codes and lots: Part number X077-0420, lot number 041218

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1884-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1884-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-03	2017-04-27

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)