FDA Device recall Z-1878-2017
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T…
- FDA Device
- Class II
- terminated
- Published 2017-05-03
On 2017-05-03 the FDA classified a Class II recall of uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T… by Ulrich Medical Usa, citing surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1878-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-07 |
| Published | 2017-05-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ulrich Medical Usa |
| Distribution | US |
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
Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
Identifiers
| code_info | 043605, U010751, U010759, U011072, U012021, U012022, U012885, 043606, U010752, U010760, U012023, U012886, 043607, U0107…043605, U010751, U010759, U011072, U012021, U012022, U012885, 043606, U010752, U010760, U012023, U012886, 043607, U010753, U010761, U012024, U012887, 043608, U010754, U010762, U012025, U012888, 043609, U010755, U010763, U012026, U012889, 043610, U010756, U010764, U012027, U012890, 043611, U010757, U010765, U012028, U012891, 043612, U010758, U010766, U012029, U012892, 043613, U010149, U010769, U012038, U012541, U012893, 043614, U010148, U010770, U012039, U012894, 043615, U010147, U010771, U012040, U012895, 043616, U010146, U010772, U012041, U012539, U012540, U012896, 043617, U010145, U010773, U012042, U012897, 043618, U010144, U010774, U010963, U012043, U012898, 043619, U010143, U010775, U012044, U012899, 043498, U010142, U012045, U012900, U101776, 043621, U010141, U010777, U012046, U012901, 043622, U010140, U010778, U012047, U012902, 043623, U010193, U010711, U010973, U011066, U012058, U012903, 043624, U010192, U010712, U010972, U011067, U012059, U012650, U012651, U012904, 043625, U010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1878-2017%22
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