MAGEC recallZ-1657-2025 · Globus Medical, Inc. · initiated Apr 3, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Globus Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On April 3, 2025, URGENT: MEDICAL DEVICE NOTIFICATION letter was sent to their customer. Actions to be taken by Customers/Users The customer is instructed to monitor their patient closely for any potential adverse events. Report any adverse events believed to be associated with this notification to Globus Medical. In addition, any adverse events associated with the use of this product and/or quality problems should also be reported to the FDA's MedWatch Program: MedWatch: The FDA Safety Information and Adverse Event Reporting Program; For Questions and Support: Globus Medical Complaint Handling Unit: Email: [email protected] Globus Medical is committed to serving your product needs and our primary objectives are patient safety, exceptional product reliability, and the highest level of customer satisfaction. Thank you for your prompt support on this important matter. We appreciate your cooperation.
Recall details
- Recall number
- Z-1657-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 3, 2025
- Posted by the FDA
- Apr 23, 2025
- Recalling firm
- Globus Medical, Inc.
- Quantity
- 1 unit
- Product code
- PGN
- FDA submissions
- K171791
- Distribution
- US Nationwide distribution in the state of AR.
Product description
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Code information (models, lots, serial numbers)
Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MAGEC MC2-5090SNuvasive, Inc. · Growing rod system- magnetic actuation1 recall33 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K171791 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- MAGEC MC2-5070SNuvasive, Inc. · Growing rod system- magnetic actuation23 reports
- MAGEC MC2-5090RNuvasive, Inc. · Growing rod system- magnetic actuation12 reports
- MAGEC MC2-5070RNuvasive, Inc. · Growing rod system- magnetic actuation9 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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