NuVasive MAGEC 2 Spinal Rods Recalled for Actuator Separation
NuVasive Inc. is recalling MAGEC 2 spinal rods because actuator end caps may separate, exposing internal components and releasing titanium wear debris.
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: The recall is classified as FDA Class II. The hazard involves a risk of harm (tissue discoloration and component degeneration) from an implanted device, but the source text does not report any specific injuries, hospitalizations, or fatalities, placing it in the 'High' severity category per the rubric.
Plain-English summary
NuVasive Inc. is recalling 3,502 units of the MAGEC 2 Rod, a sterile single-use spinal rod used in surgical implantation. The recall covers various sizes and configurations, including 4.5mm, 5.0mm, 5.5mm, and 6.0mm diameters, in both standard and offset lengths.
The recall is due to a potential post-implantation separation of an actuator end cap component. This separation may expose the internal components of the actuator, which could lead to hastened degeneration of these parts. Consequently, titanium alloy wear debris may escape, resulting in localized tissue discoloration.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. Patients who have had these devices implanted should contact their healthcare provider for evaluation and guidance.
The recalled product
- Product
- NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline, Reline Small Stature, and Armada fixation components (i.e. Pedicle screws, hooks…
- Manufacturer
- NuVasive Inc
- Category
- Medical Device — Spinal Implant
- Affected units
- 3,502
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 (1)
- Part Number: MC2-4570R Product: MAGEC 2 ROD
Distribution
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