Reported Feb 2, 2022 · Ongoing
MAGEC 1 System
NuVasive Specialized Orthopedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NuVasive Specialized Orthopedics, Inc. · 101 Enterprise Ste 100 · Aliso Viejo, CA · 92656-2604
Is this the product you have?
- MAGEC 1 System
- Lot codes and dates
- All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015.
- Amount recalled
- 3,056 devices
Why it was recalled
Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
This product could cause temporary or reversible health problems — stop using it.
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