FDA Device recall Z-1244-2021
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical fi…
- FDA Device
- Class II
- ongoing
- Published 2021-03-17
On 2021-03-17 the FDA classified a Class II recall of CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical fi… by Rti Surgical Dba Pioneer Surgical Technology, citing locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1244-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-01-15 |
| Published | 2021-03-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Rti Surgical Dba Pioneer Surgical Technology |
| Distribution | US |
Product
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
Reason
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Identifiers
| code_info | Batch Number: 330972 330973 338829 344097 344098 350514 350515 352677 358455 361801 361802 364748 367803…Batch Number: 330972 330973 338829 344097 344098 350514 350515 352677 358455 361801 361802 364748 367803 369335 370391 370392 377187 379016 379539 379540 379541 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1244-2021%22
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