FDA Device recall Z-1657-2025
MAGEC 2 Rod, 5.0mm 90mm Standard
- FDA Device
- Class II
- ongoing
- Published 2025-04-30
On 2025-04-30 the FDA classified a Class II recall of MAGEC 2 Rod, 5.0mm 90mm Standard by Globus Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1657-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-03 |
| Published | 2025-04-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Globus Medical |
| Distribution | US |
Product
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
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.
Identifiers
| code_info | Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1657-2025%22
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