Product Safety Recalls

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NuVasive Specialized Orthopedics, Inc. Recall 89177

Description: MAGEC 1 System

NuVasive Specialized Orthopedics, Inc. Recall 89177 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0528-2022
Event ID89177
Event DescriptionMAGEC 1 System
Product TypeDevices
DistributionWorldwide
Quantity3,056 devices
Recall ReasonSafety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
Device Classification20220202
Device Code InfoAll MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015.
Center Classification Date20220126
Recall Initiation Date20190625
Recalling FirmNuVasive Specialized Orthopedics, Inc.
Initial Notification Letter
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