Class II — Globus Medical, Inc.
| Recalling firm | Globus Medical, Inc |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of AR. |
| Initiated | 2025-04-03 |
| Classified | 2025-04-23 |
| Recall number | Z-1657-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Globus Medical, Inc. (Z-1657-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96615/
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