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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.

FDA Recall Z-1878-2017 · Posted 2017-04-26

Recalling FirmUlrich Medical USA Inc
Recall StatusTerminated
Product CodeKWQ
Date Initiated2017-03-07
Date Terminated2017-11-30
Product Quantity4,854 plates

Reason for Recall

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

Firm 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.

Root Cause

Use error

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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