FDA Device recall Z-1216-2021
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - 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, 36mm Material Number: 66-236 - 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-1216-2021 |
| 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, 36mm Material Number: 66-236 - 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: 332500 338833 344102 350520 353384 361807 364751 364752 369338 377190 379080 380872 |
|---|
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-1216-2021%22
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