Ulrich Medical USA Inc recalls uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cer…

Recall date

March 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1878-2017

FDA classification

Class II

Brand / firm

Ulrich Medical USA Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.