Back 2 Basics Direct LLC: Medical Device Recall in 2018 - (Recall #: Z-2881-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: June 29, 2018

Date Posted: August 29, 2018

Recall Number: Z-2881-2018

Event ID: 80639

Reason for Recall:

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

Status: Terminated

Product Quantity: 10

Code Information:

Lot 779C4

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated