Recall Z-2881-2018— Back 2 Basics Direct LLC

Name: FDA recall Z-2881-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-29

Class II · Terminated

Class II FDA medical device recall by Back 2 Basics Direct LLC, initiated 2018-06-29, terminated 2018-11-15. It names one FDA 510(k) clearance: K150184. 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..

Recalling firm: Back 2 Basics Direct LLC
Classification: Class II
Status: Terminated
Initiated: 2018-06-29
Terminated: 2018-11-15
Firm location: Independence, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K150184 — Dymaxeon Spine SystemBack 2 Basics Direct, LLC·cleared 2015-06-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.