Summary
The FDA issued a Class II for MAGEC 1 System by NuVasive Specialized Orthopedics, Inc.. Reason: Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26.
Details
Source
Device Recall
External ID
Z-0528-2022
Action Date
2022-02-02
Status
Ongoing
Category
device
Product Description
MAGEC 1 System
Lot/Code Info: All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015.
Quantity Affected: 3,056 devices
Reason for Recall
Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2019-06-25
Company
Aliso Viejo, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 97 device recalls issued in the same week, part of 403 device-related FDA actions this month.
NuVasive Specialized Orthopedics, Inc. has 6 FDA actions in our database, including 4 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NuVasive Specialized Orthopedics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NuVasive Specialized Orthopedics, Inc. have FDA actions?
NuVasive Specialized Orthopedics, Inc. has 6 FDA actions in our database, including 4 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0528-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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