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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
Recalled August 29, 2018 · FDA recall Z-2881-2018 · Back 2 Basics Direct
Hazard
Packages labeled as containing 110mm rods may contain 100mm rods. · FDA Class II
Units
10
Sold at
The products were distributed to the following US states: OH.
Description
Packages labeled as containing 110mm rods may contain 100mm rods.
Product
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).
Manufacturer(s)
Back 2 Basics Direct LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →