uNion Cervical Plate System Product Usage: The uNion Cervical Plate… — Class II medical device recall Z-1878-2017
Terminated recall by Ulrich Medical USA Inc, reported 2017-05-03, distributed nationwide. Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
| Recall number | Z-1878-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ulrich Medical USA Inc, Chesterfield, MO, United States |
| Recall initiated | 2017-03-07 |
| Classified | 2017-04-25 |
| Reported by FDA | 2017-05-03 |
| Terminated | 2017-11-30 |
| Distributed | Nationwide (US) |
| Quantity | 4,854 plates |
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.
Reason for recall
Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.