Z-2881-2018Class II

Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B

Name: Z-2881-2018 Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B
Creator: Back 2 Basics Direct LLC
Published: 2018-06-29
License: https://open.fda.gov/license/

Back 2 Basics Direct, LLC / initiated 2018-06-29 / Terminated / root cause: labeling and UDI

FDA source

Back 2 Basics Direct LLC began a 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 immobilization and... on 2018-06-29. FDA classified it as Class II and gives the reason as "Packages labeled as containing 110mm rods may contain 100mm rods". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2881-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-29
Posted: 2018-08-21
Terminated: 2018-11-15
Recalling firm: Back 2 Basics Direct, LLC
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).
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Packages labeled as containing 110mm rods may contain 100mm rods.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Customers were contacted via phone the week of 3/5/18 and 7/12/18. The customers were informed of the recall and asked any of the affected remained in their possession, if the products have already been implanted, and if any patients experienced any adverse events.
Quantity in commerce: 10
Distribution: The products were distributed to the following US states: OH.
Product codes and lots: Lot 779C4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2881-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2881-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-21

Product code NKB

K150184Class IIDymaxeon Spine SystemBack 2 Basics Direct, LLC / cleared 2015-06-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)