CervAlign Anterior Cervical Plate System-Cervalign — Class II medical device recall Z-1225-2021
Ongoing recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), reported 2021-03-17, distributed nationwide. Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in re
| Recall number | Z-1225-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Marquette, MI, United States |
| Recall initiated | 2021-01-15 |
| Classified | 2021-03-11 |
| Reported by FDA | 2021-03-17 |
| Distributed | Nationwide (US) |
| Lot numbers | 333152, 338845, 341493, 347126, 351531, 355537, 359848, 364534, 364971, 369364, 370407, 378060, 380152 |
Product
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - 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 for recall
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1225-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.