# FDA recall Z-2881-2018

> **Back 2 Basics Direct LLC** · Class II · device recall initiated 2018-06-29.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-2881-2018
- **Recalling firm:** Back 2 Basics Direct LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-29
- **Report date:** 2018-08-29
- **Termination date:** 2018-11-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Independence, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2881-2018

## Citation

> AI Analytics. FDA recall Z-2881-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-2881-2018. Source: US FDA. Licensed CC0.

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