BEUDAMED
    FDA Recall Terminated

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    Recall: Z-1878-2017 · Initiated March 7, 2017

    Recall

    Recall Number
    Z-1878-2017
    Event Number
    76740
    Firm
    Ulrich Medical USA Inc
    FEI Number
    3005532635
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    March 7, 2017
    Posted
    April 26, 2017
    Terminated
    November 30, 2017
    Address
    18221 Edison Ave, Chesterfield, MO, 63005-3703

    Description

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    Reason

    Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.

    Action

    On March 7, 2017, the recalling firm sent letters by mail informing customers of the field correction along with the updated surgical technique which contains the enhanced cautionary statement. Customers were instructed to destroy older versions of the surgical technique. The letters also contained a link to the recalling firm's website on which the recalling firm posted the current, updated copy of the surgical technique.

    Distribution

    US Nationwide in the states of: AL, AR, AZ, CA, CT, FL, GA, ID, IL, KS, LA, MO, MS, NY, OH, OK, OR, TN, TX, and WI

    Quantity

    4,854 plates