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).
FDA Recall Z-2881-2018 · Posted None
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Recalling FirmBack 2 Basics Direct LLC
Recall StatusTerminated
Product CodeNKB
Date Initiated2018-06-29
Date Terminated2018-11-15
Product Quantity10
Reason for Recall
Packages labeled as containing 110mm rods may contain 100mm rods.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
The products were distributed to the following US states: OH.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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