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
Product summary
- 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
Packages labeled as containing 110mm rods may contain 100mm rods.