FDA Device recall Z-1221-2021
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical f…
- 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, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical f… 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-1221-2021 |
| 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, 3 Level, 45mm Material Number: 66-345 - 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: 333017 333018 338838 346883 346884 351525 354404 358458 359841 364531 369361 370402 377835 377836 379927 |
|---|
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-1221-2021%22
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