The Recall Desk
HighFDA (Devices)·Z-1657-2025·Announced 2025-04-30

Globus Medical MAGEC 2 Rod recalled for incorrect outer diameter assembly

Globus Medical is recalling MAGEC 2 Rod model MC2-5090S devices because certain units were assembled with a 5.5mm outer diameter rod instead of the required 5.0mm specification.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a structural defect (incorrect outer diameter specification) in an implantable orthopedic device. Although the source text does not report any illnesses or injuries, the dimensional assembly error in a critical component of a spinal distraction rod presents a risk of harm due to potential malfunction.

Plain-English summary

Globus Medical, Inc. is recalling MAGEC 2 Rod, 5.0mm 90mm Standard (Model MC2-5090S) devices due to a manufacturing defect. Devices in the affected lot were not assembled according to product specifications.

The distraction rod outer diameter was assembled with a 5.5mm rod instead of the required 5.0mm diameter. This deviation from specifications could affect the proper function and safety of the implant.

The recall affects MAGEC 2 Rod devices with Version/Model MC2-5090S distributed nationwide in Arkansas. The affected lot can be identified by UDI-DI (01)00887517834041(11)250311(17)300311(10)GB1607ET. Patients and healthcare providers who have received or implanted these devices should contact Globus Medical, Inc. for further guidance regarding their specific devices.

The recalled product

Product
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Manufacturer
Globus Medical, Inc.
Category
Medical Device — Orthopedic / Spinal Implant
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Version/Model: MC2-5090S
  • UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

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