NUVASIVE MAGEC 2 Rod Spinal Bracing System Recalled for Sterile Packaging Failure
NuVasive is recalling the MAGEC 2 Rod spinal bracing system due to potential failure of the sterile packaging barrier, which could compromise device sterility.
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 recall of an implanted orthopedic device. Although no illnesses or injuries have been reported, the potential failure of the sterile packaging barrier in an implanted spinal device represents a risk-of-harm scenario, meeting the rubric criterion for High severity.
Plain-English summary
NuVasive Specialized Orthopedics, Inc. is recalling certain MAGEC 2 Rod devices used in the MAGEC System, a spinal bracing system designed to treat scoliosis in growing children. The recall includes 16 different model configurations with varying rod diameters and lengths, totaling 1,873 units.
During accelerated shelf-life extension studies, researchers identified a potential failure point in the sterile packaging barrier. If the sterile packaging fails, the device may no longer be sterile when implanted, creating a risk of infection.
The affected units have been distributed in the United States (including Puerto Rico), Chile, Israel, Jordan, New Zealand, Singapore, Sweden, Thailand, and the United Arab Emirates. Patients and healthcare providers should identify any affected devices using the specific lot numbers provided with this recall.
Healthcare providers should halt use of affected units identified by lot number. Patients with an implanted MAGEC 2 Rod should contact their surgeon or healthcare provider to determine if their device is part of this recall.
The recalled product
- Product
- NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2…
- Manufacturer
- NuVasive Specialized Orthopedics, Inc.
- Affected units
- 1,873
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)
- 5.5
Distribution
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