Recall Z-2881-2018 ยท NKB Thoracolumbosacral Pedicle Screw System
Back 2 Basics Direct LLC
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 dis
| Date | Jun 29, 2018 |
| Status | Terminated |
| Reason | Packages labeled as containing 110mm rods may contain 100mm rods. |
| 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 | 10 |
| Distribution | The products were distributed to the following US states: OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150184 | Dymaxeon Spine System Back 2 Basics Direct, LLC, Jun 15, 2015 |