Device product

MAGEC 1 System

Z-0528-2022

June 25, 2019

Class II

Product summary

Firm: NuVasive Specialized Orthopedics, Inc.
Event: Event 89177
Status: Ongoing
Classification: Class II
Quantity: 3,056 devices
Official record key: device-enforcement:Z-0528-2022

Official wording

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.

Code information: All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015.

Distribution pattern: Worldwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.