Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow) Recalled by Back 2 Basics Direct LLC Due to Packages labeled as containing 110mm rods may contain...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Back 2 Basics Direct LLC directly.
Affected Products
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).
Quantity: 10
Why Was This Recalled?
Packages labeled as containing 110mm rods may contain 100mm rods.
Where Was This Sold?
This product was distributed to 1 state: OH
About Back 2 Basics Direct LLC
Back 2 Basics Direct LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report