Z-1657-2025Class II

MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S

Name: Z-1657-2025 MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S
Creator: Globus Medical, Inc.
Published: 2025-04-03
License: https://open.fda.gov/license/

Globus Medical, Inc. / initiated 2025-04-03 / Open, Classified / root cause: manufacturing process

FDA source

Globus Medical, Inc. began a recall of MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S on 2025-04-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1657-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-03
Posted: 2025-04-23
Recalling firm: Globus Medical, Inc.
Product: MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Product code: PGN Growing Rod System- Magnetic Actuation
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of AR.
Product codes and lots: Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1657-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1657-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-23

Product code PGN

K171791Class IIMAGEC® SystemNuvasive Specialized Orthopedics, Incorporated / cleared 2017-08-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)