FDA Device recall Z-1884-2017
5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420
- FDA Device
- Class II
- terminated
- Published 2017-05-03
On 2017-05-03 the FDA classified a Class II recall of 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420 by Xtant Medical, citing the material type on the label may incorrectly state Ti6Al-4V ELI . The rods are composed of Cobalt Chromium.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1884-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-12 |
| Published | 2017-05-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Xtant Medical |
| Distribution | US |
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).
Reason
The material type on the label may incorrectly state Ti6Al-4V ELI . The rods are composed of Cobalt Chromium.
Identifiers
| code_info | Part number X077-0420, lot number 041218 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1884-2017%22
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