MAGEC 1 System Recalled for Post-Implantation Component Fractures
The MAGEC 1 System implantable medical device is being recalled due to documented post-implantation fractures of an internal metallic component. The recall affects approximately 3,056 units manufactured before March 26, 2015 and distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 documented structural failure (post-implantation metallic component fractures) in an implantable device. Per the severity rubric, a risk-of-harm product where injury has not yet been explicitly reported in the source text scores at a maximum of 3 (High).
Plain-English summary
The FDA has issued a Safety Alert regarding the MAGEC 1 System, an implantable medical device manufactured by NuVasive Specialized Orthopedics, Inc. All units manufactured prior to March 26, 2015 are subject to this recall, affecting approximately 3,056 devices distributed worldwide.
The alert concerns post-implantation fractures of an internal metallic component within the device. This structural failure occurs after implantation and represents a potential safety risk.
Surgeons and other healthcare providers have been notified via this Safety Alert. Patients with implanted MAGEC 1 Systems manufactured before March 26, 2015 should contact their healthcare provider to discuss their device and any necessary follow-up.
The recalled product
- Product
- MAGEC 1 System
- Manufacturer
- NuVasive Specialized Orthopedics, Inc.
- Affected units
- 3,056
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)
- All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26
- 2015.
Distribution
Distribution scope not specified by the agency.
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