Recall Z-1884-2017— XTANT MEDICAL INC

Name: FDA recall Z-1884-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-12

Class II · Terminated

Class II FDA medical device recall by XTANT MEDICAL INC, initiated 2017-04-12, terminated 2017-08-16. It names one FDA 510(k) clearance: K120832. 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..

Recalling firm: XTANT MEDICAL INC
Classification: Class II
Status: Terminated
Initiated: 2017-04-12
Terminated: 2017-08-16
Firm location: Belgrade, MT, United States

510(k) clearances named in this recall

1 on FDA's record

K120832 — FORTEX PEDICLE SCREW SYSTEMX-Spine Systems, Inc.·cleared 2012-10-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.

Data sourced from openFDA. This site is unofficial and independent of the FDA.