Date Initiated by Firm |
June 29, 2018 |
Create Date |
August 21, 2018 |
Recall Status1 |
Terminated 3 on November 15, 2018 |
Recall Number |
Z-2881-2018 |
Recall Event ID |
80639 |
510(K)Number |
K150184
|
Product Classification |
Thoracolumbosacral pedicle screw system - Product Code NKB
|
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).
|
Code Information |
Lot 779C4 |
Recalling Firm/ Manufacturer |
Back 2 Basics Direct LLC 6701 Rockside Rd Ste 200 Independence OH 44131-2316
|
For Additional Information Contact |
Mitchell 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 |
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. |
Total Product Life Cycle |
TPLC Device Report
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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) Database |
510(K)s with Product Code = NKB and Original Applicant = Back 2 Basics Direct, LLC
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