XTANT MEDICAL INC recalls 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piec…

Recall date

April 12, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1884-2017

FDA classification

Class II

Brand / firm

XTANT MEDICAL INC

Sold / distributed

Worldwide distribution - US Nationwide in the states of: AZ, CA, CT, GA, LA, NV, OH, TX and in the country of Mexico.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).