Atec Insignia Anterior Cervical Plate System — Class II medical device recall Z-1820-2021
Terminated recall by Alphatec Spine, Inc., reported 2021-06-16, distributed nationwide. There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate in
| Recall number | Z-1820-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alphatec Spine, Inc., Carlsbad, CA, United States |
| Recall initiated | 2021-04-26 |
| Classified | 2021-06-07 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2022-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| UPC / GTIN / UDI-DI | 00190376268606 |
| Model numbers | 136-0358 |
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606
Reason for recall
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
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-1820-2021. 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.