Back 2 Basics Direct LLC recalls Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is in…

Recall date

June 29, 2018

Source

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

Recall number

Z-2881-2018

FDA classification

Class II

Brand / firm

Back 2 Basics Direct LLC

Sold / distributed

The products were distributed to the following US states: OH.

Why it was recalled

Packages labeled as containing 110mm rods may contain 100mm rods.

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

What was recalled

Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine 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 thoracic, lumbar, and sacral/iliac spine (T1 S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).