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U.S. Department of Health and Human Services

Class 2 Device Recall Dymaxeon Spine System

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 Class 2 Device Recall Dymaxeon Spine Systemsee related information
Date Initiated by FirmJune 29, 2018
Create DateAugust 21, 2018
Recall Status1 Terminated 3 on November 15, 2018
Recall NumberZ-2881-2018
Recall Event ID 80639
510(K)NumberK150184 
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
ProductDymaxeon 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).
Code Information Lot 779C4
FEI Number 3011170426
Recalling Firm/
Manufacturer		 Back 2 Basics Direct LLC
6701 Rockside Rd Ste 200
Independence OH 44131-2316
For Additional Information ContactMitchell Bass
858-447-5025
Manufacturer Reason
for Recall		Packages labeled as containing 110mm rods may contain 100mm rods.
FDA Determined
Cause 2		Labeling mix-ups
ActionCustomers 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 Commerce10
DistributionThe products were distributed to the following US states: OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NKB
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