BEUDAMED
    FDA Recall Terminated

    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).

    Recall: Z-2881-2018 · Initiated June 29, 2018

    Recall

    Recall Number
    Z-2881-2018
    Event Number
    80639
    Firm
    Back 2 Basics Direct LLC
    FEI Number
    3011170426
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 29, 2018
    Terminated
    November 15, 2018
    Address
    6701 Rockside Rd, Ste 200, Independence, OH, 44131-2316

    Description

    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).

    Reason

    Packages labeled as containing 110mm rods may contain 100mm rods.

    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.

    Distribution

    The products were distributed to the following US states: OH.

    Quantity

    10