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Recall Observatory FDA recall evidence

Device 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).

Z-2881-2018

June 29, 2018

Class II

Product summary

Firm
Back 2 Basics Direct LLC
Event
Event 80639
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-2881-2018

Official wording

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

Code information: Lot 779C4

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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