CLASS II ONGOING Device recall · Reported 30 Apr 2025 · FDA Enforcement Report
Magec 2 Rod Standard recalled by Globus Medical
Globus Medical is recalling Magec 2 Rod Standard, distributed nationwide in the US. The recall was initiated on 3 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1657-2025
- FDA event ID
- 96615
- Recalling firm
- Globus Medical, West Norriton, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Apr 2025
- FDA classified
- 23 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Apr 2025 | Recall initiated by company | |
| 23 Apr 2025 | Classified by FDA | +20 days |
| 30 Apr 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Where it was distributed
US Nationwide distribution in the state of AR.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET
Where was it sold?
US Nationwide distribution in the state of AR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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