Class II — Ulrich Medical USA Inc
| Recalling firm | ULRICH MEDICAL USA, INC. |
|---|---|
| Registered facility | ULRICH MEDICAL USA, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 fusio… |
| Quantity | 4,854 plates |
| 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 |
| Initiated | 2017-03-07 |
| Classified | 2017-04-25 |
| Terminated | 2017-11-30 |
| Recall number | Z-1878-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ulrich Medical USA Inc (Z-1878-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76740/
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