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

Recalled May 3, 2017 · FDA recall Z-1878-2017 · Ulrich Medical USA

Hazard

Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating. · FDA Class II

Units

4,854 plates

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Ulrich Medical USA Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →