MAGEC 2 Rod — Class II medical device recall Z-1657-2025
Ongoing recall by Globus Medical, Inc., reported 2025-04-30, distributed nationwide. Devices for the affected lot were not assembled according to product specifications. The distraction rod outer
| Recall number | Z-1657-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Globus Medical, Inc., West Norriton, PA, United States |
| Recall initiated | 2025-04-03 |
| Classified | 2025-04-23 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 00887517834041 |
| Model numbers | MC2-5090S |
Product
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Reason for recall
Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
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-1657-2025. 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.