Dymaxeon 5 — Class II medical device recall Z-2881-2018
Terminated recall by Back 2 Basics Direct LLC, reported 2018-08-29. Packages labeled as containing 110mm rods may contain 100mm rods.
| Recall number | Z-2881-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Back 2 Basics Direct LLC, Independence, OH, United States |
| Recall initiated | 2018-06-29 |
| Classified | 2018-08-21 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2018-11-15 |
| Quantity | 10 |
| Reason classes | labeling |
| Lot numbers | 779C4 |
| Model numbers | 06.6441B |
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 for recall
Packages labeled as containing 110mm rods may contain 100mm rods.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2881-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.