MAGEC 1 System — Class II medical device recall Z-0528-2022
Ongoing recall by NuVasive Specialized Orthopedics, Inc., reported 2022-02-02. Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component f
| Recall number | Z-0528-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NuVasive Specialized Orthopedics, Inc., Aliso Viejo, CA, United States |
| Recall initiated | 2019-06-25 |
| Classified | 2022-01-26 |
| Reported by FDA | 2022-02-02 |
| Quantity | 3,056 devices |
| Reason classes | device malfunction |
Product
MAGEC 1 System
Reason for recall
Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
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-0528-2022. 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.