NuVasive Specialized Orthopedics, Inc. Recall 89177
Description: MAGEC 1 System
NuVasive Specialized Orthopedics, Inc. Recall 89177 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0528-2022 |
Event ID | 89177 |
Event Description | MAGEC 1 System |
Product Type | Devices |
Distribution | Worldwide |
Quantity | 3,056 devices |
Recall Reason | Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015. |
Device Classification | 20220202 |
Device Code Info | All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015. |
Center Classification Date | 20220126 |
Recall Initiation Date | 20190625 |
Recalling Firm | NuVasive Specialized Orthopedics, Inc. |
Initial Notification | Letter |
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