Summary
The FDA issued a Class II for MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; by Globus Medical, Inc.. Reason: Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm ro.
Details
Source
Device Recall
External ID
Z-1657-2025
Action Date
2025-04-30
Status
Ongoing
Category
device
Product Description
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Lot/Code Info: Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET
Quantity Affected: 1 unit
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.
Distribution
US Nationwide distribution in the state of AR.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-03
Company
West Norriton, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Globus Medical, Inc. has 40 FDA actions in our database, including 6 recalls and 34 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Globus Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Globus Medical, Inc. have FDA actions?
Globus Medical, Inc. has 40 FDA actions in our database, including 6 recalls and 34 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1657-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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