medical Class II Updated 2018-08-29

Back 2 Basics Direct LLC recalls Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Num

Recalled 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).


Hazard / Issue

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

Issued by

FDA

Affected States: OH
Lot/Code Info: Lot 779C4
View official government recall

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