FDA Device recall Z-2881-2018
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 im…
- FDA Device
- Class II
- terminated
- Published 2018-08-29
On 2018-08-29 the FDA classified a Class II recall of 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 im… by Back 2 Basics Direct, citing packages labeled as containing 110mm rods may contain 100mm rods.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2881-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-29 |
| Published | 2018-08-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Back 2 Basics Direct |
| Distribution | OH |
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).
Reason
Packages labeled as containing 110mm rods may contain 100mm rods.
Identifiers
| code_info | Lot 779C4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2881-2018%22
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