FDA Medical devices recall ·
MAGEC 2 Rod, 5.0mm 90mm Standard recall
- Recall number
- Z-1657-2025
- Date
- (initiated April 3, 2025)
- Company / brand
- Globus Medical, Inc.
2560 General Armistead Ave, West Norriton, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET
Distribution
US Nationwide distribution in the state of AR.
States: Arkansas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1657-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.