FDA Device recall Z-1223-2021
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - 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, 3Level, 51mm Material Number: 66-351 - 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-1223-2021 |
| 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, 3Level, 51mm Material Number: 66-351 - 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: 333021 333022 338840 341489 343445 346886 351527 351528 351528 351528 351528 351528 351528…Batch Number: 333021 333022 338840 341489 343445 346886 351527 351528 351528 351528 351528 351528 351528 358459 358459 358459 358459 358459 358459 362405 363444 364766 364766 369197 369197 370268 377838 377838 379930 379930 379930 379930 379931 379931 385407 |
|---|
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-1223-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.